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Preoperative vaginal preparation with antiseptic solution in cesarean birth : a clinical practice guideline Kim, Esther 2020-03

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PREOPERATIVE VAGINAL PREPARATION WITH ANTISEPTIC SOLUTION IN CESAREAN BIRTH: A CLINICAL PRACTICE GUIDELINE by  ESTHER KIM  B.A., Simon Fraser University, 2013 B.S.N., British Columbia Institute of Technology, 2016  A SCHOLARLY PRACTICE ADVANCEMENT RESEARCH PROJECT SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF  MASTER OF SCIENCE in THE FACULTY OF GRADUATE AND POSTDOCTORAL STUDIES (Nursing)  THE UNIVERSITY OF BRITISH COLUMBIA (Vancouver)  March 2020  © Esther Kim, 2020 ii  The following individuals certify that they have read, and recommend to the Faculty of Graduate and Postdoctoral Studies for acceptance, a thesis/dissertation entitled:  Preoperative Vaginal Preparation with Antiseptic Solution in Cesarean Birth: A Clinical Practice Guideline   submitted by Esther Kim in partial fulfillment of the requirements for the degree of Master of Science in Nursing in The Faculty of Graduate and Postdoctoral Studies  Examining Committee: Dr. Helen J. Brown Supervisor  Melanie Basso Supervisory Committee Member  iii  Abstract Infectious morbidities remain the most common post-cesarean complication despite prophylactic measures to reduce the risk of infection. Infectious morbidities have significant implications for both the mother and her infant(s). Current empirical evidence suggests that vaginal preparation with an antiseptic solution immediately prior to cesarean birth reduces the risk of infectious morbidities—namely endometritis—in women who were in labour and/or with ruptured membranes prior to CS. However, there are no clear recommendations for the use of vaginal preparation. This culminating project critically analyzes the literature on pre-cesarean vaginal preparation and develops a clinical practice guideline based on the literature review to standardize and guide healthcare providers’ patient care. The findings suggest that vaginal preparation with povidone-iodine or chlorhexidine decreases the incidence of postpartum endometritis. Implications for nursing include the implementation of vaginal preparation within a care bundle and further research to confirm the findings.  iv  Preface This culminating project is an independent, original, and unpublished work by the author. The literature search was conducted with the guidance of Katherine Miller, the UBC Reference Librarian for the School of Nursing. The literature review, critical analysis, and conclusions were drafted independently by the author and supervised by Dr. Helen J. Brown and Melanie Basso, the committee members. All revisions of the manuscript were reviewed and approved by the committee members. Ethics approval was not required for this project. v  Table of Contents Abstract .................................................................................................................................... iii Preface ...................................................................................................................................... iv Table of Contents ...................................................................................................................... v List of Figures .......................................................................................................................... ix List of Abbreviations ................................................................................................................ x Acknowledgements ................................................................................................................. xii Dedication .............................................................................................................................. xiii Chapter 1: Introduction ........................................................................................................... 1 1.1 Background ................................................................................................................. 2 1.1.1 Postpartum endometritis ...................................................................................... 2 1.1.2 Vaginal preparation.............................................................................................. 2 1.1.3 Antiseptic solutions ............................................................................................. 3 1.1.4 Clinical practice guideline (CPG)......................................................................... 3 1.1.5 Trauma- and violence-informed care (TVIC) ....................................................... 4 1.2 Significance of the issue .............................................................................................. 5 1.2.1 Personal significance ........................................................................................... 5 1.2.2 Clinical significance ............................................................................................ 6 1.3 Purpose of project ........................................................................................................ 6 Chapter 2: Methodology ........................................................................................................... 8 2.1 Researchable question ................................................................................................. 8 2.2 Systematic search ........................................................................................................ 8 2.2.1 Systematic search process .................................................................................... 8 vi  2.2.2 Literature selection process ................................................................................ 10 2.2.3 Critical appraisal process ................................................................................... 12 2.2.4 Synthesis processes and procedures ................................................................... 12 2.3 Theoretical perspectives ............................................................................................ 12 Chapter 3: Findings ................................................................................................................ 14 3.1 Key characteristics of main findings .......................................................................... 14 3.1.1 Types of study design and location of study ....................................................... 14 3.1.2 Sample description............................................................................................. 14 3.1.2.1 Primary studies .............................................................................................. 15 3.1.2.2 Systematic reviews......................................................................................... 15 3.1.3 Inclusion and exclusion criteria .......................................................................... 15 3.1.3.1 Primary studies .............................................................................................. 15 3.1.3.2 Systematic reviews......................................................................................... 16 3.1.4 Interventions and controls .................................................................................. 16 3.1.4.1 Type of antiseptic solution ............................................................................. 16 3.1.4.2 Method of vaginal preparation ....................................................................... 17 3.1.4.3 Types of controls ........................................................................................... 18 3.1.5 Outcome measures ............................................................................................. 19 3.1.6 Source of funding .............................................................................................. 19 3.1.7 Declaration of interest ........................................................................................ 19 3.2 Synthesis of main findings ......................................................................................... 19 3.3 Summary of critical appraisal .................................................................................... 21 3.3.1 Strengths ............................................................................................................ 21 vii  3.3.2 Limitations ........................................................................................................ 24 Chapter 4: Discussion and Recommendations ....................................................................... 27 4.1 Discussion ................................................................................................................. 27 4.1.1 Gaps in literature ............................................................................................... 27 4.1.2 Strengths ............................................................................................................ 29 4.1.3 Limitations ........................................................................................................ 30 4.2 Recommendations ..................................................................................................... 30 4.2.1 Clinical practice guideline .................................................................................. 31 4.2.1.1 Background.................................................................................................... 31 4.2.1.2 Operational definition .................................................................................... 32 4.2.1.3 Expected outcomes ........................................................................................ 32 4.2.1.4 Eligibility criteria ........................................................................................... 32 4.2.1.5 Exclusion criteria ........................................................................................... 32 4.2.1.6 Step-by-step procedure................................................................................... 33 4.2.1.7 Required documentation ................................................................................ 34 4.2.2 Recommendations and implications for clinical practice .................................... 34 4.2.2.1 Care bundle .................................................................................................... 34 4.2.2.2 Trauma- and violence-informed care (TVIC) ................................................. 35 4.2.3 Recommendations and implications for future research ...................................... 35 4.3 Conclusion ................................................................................................................ 36 References ............................................................................................................................... 38 Appendices .............................................................................................................................. 51 Appendix A: Systematic search strategy ................................................................................ 51 viii  Appendix B: Matrix for key research components ................................................................. 57 ix  List of Figures Figure 1 Modified PRISMA 2009 flow diagram........................................................................ 11  x  List of Abbreviations ACOG  American college of Obstetricians and Gynecologists BMI  Body mass index CINAHL Cumulative Index to Nursing and Allied Health Literature CPG  Clinical practice guideline CS  Cesarean section ERAS  Enhanced recovery after surgery FDA  Food and Drug Administration FECG  Fetal electrocardiogram; fetal scalp electrode GBS  Group B Streptococcus HCP  Healthcare provider HIV  Human immunodeficiency virus HSV  Herpes simplex virus IUPC  Intrauterine pressure catheter JDM  Theory of judgment and decision-making KT  Knowledge translation OR  Operating room RCT  Randomized controlled trial SPAR  Scholarly Practice Advancement Research TRIP  Turning Research into Practice TVIC  Trauma- and violence-informed care USA  United States of America UTI  Urinary tract infection xi  VE  Vaginal examination  xii  Acknowledgements There is a myriad of people who have helped me along this academic journey. First and foremost, I express my gratitude to God, who has been my shield, redeemer, power, wisdom, and strength. This path is not one I could have imagined without Him.  A special thanks to my supervisor, Dr. Helen J. Brown, and my committee member, Melanie Basso, for their enduring support, encouragement, expertise, and sharing the enthusiasm for my project. Thank you for teaching me to see my project through diverse lens. I truly am grateful for all your feedback, particularly the constructive ones, as they shaped and molded my project to what it has become.  Finally, I thank my family—my mom, dad, sister, and brother—and friends whose emotional support, encouragement, prayers, patience, and belief in me has helped me find the courage to carry on. Thank you for not giving up on me, and for not allowing me to give up on myself.  xiii  Dedication I dedicated this project to my grandmother, whose faith and boldness has inspired me to dare to dream big.1  Chapter 1: Introduction Cesarean sections (CS), also referred to as cesarean deliveries or cesarean births, are common obstetrical procedures in North America; approximately 30% of births occur via CS (Haas et al., 2018; McKibben et al., 2015). Medical and non-medical reasons for performing CS include labour dystocia, multiple pregnancy, fetal malpresentation, cephalopelvic disproportion, fetal distress, antepartum hemorrhage, post-term dates, extreme fetal prematurity, fetal macrosomia, maternal infection, oligohydramnios, maternal hypertensive disorders, failed induction, fear of labour pain or childbirth, and previous CS (Aminu et al., 2014; Elnakib et al., 2019; Jenabi et al., 2019; Prosser et al., 2014; Torloni et al., 2011). While commonly performed, infectious morbidities—namely endometritis, wound infection, and febrile morbidities—remain the most common post-cesarean complication despite administration of prophylactic antibiotics and technological advances in medicine (Göymen et al., 2017; Haas et al., 2018; Zuarez-Easton et al., 2017). Infectious morbidities may lead to delayed recovery, prolonged hospital stay, readmission, and increased healthcare costs, and can negatively impact newborn care and maternal-infant attachment and bonding (Aref, 2019; Zuarez-Easton et al., 2017). Current evidence suggests that vaginal preparation (also known as vaginal cleansing, vaginal washing, or vaginal antisepsis) with an antiseptic solution, such as povidone-iodine or chlorhexidine, immediately prior to CS may reduce the risk of infectious morbidities—namely endometritis—in women who were in labour and/or with ruptured membranes prior to the cesarean birth (Caissutti et al., 2017; Memon et al., 2011; Yildirim et al., 2012). However, currently, there are no clear recommendations for the use of vaginal preparation (Haas et al., 2010; Yildirim et al., 2012). 2  1.1 Background 1.1.1 Postpartum endometritis. Endometritis is defined as the inflammation and infection of the endometrium and is categorized as acute or chronic (Kita et al., 2016). Postpartum, or puerperal, endometritis is described as an acute polymicrobial infection and inflammation of the endometrium—wherein the bacteria originates from the birth canal, normal vaginal flora, or surgical site—characterized by fever, uterine tenderness, and foul-odoured vaginal discharge past the first 24 hours post-CS (Chen, 2019; Mackeen et al., 2015; Mulic-Lutvica & Axelsson, 2007; Safrai et al., 2017). Common pathogens associated with postpartum endometritis include Staphylococcus, Streptococcus, Escherichia coli, and Enterococcus (Chen, 2019; Meaney-Delman et al., 2015). Other risk factors for postpartum endometritis include manual removal of the placenta, prolonged rupture of membranes, meconium-stained amniotic fluid, prolonged labour, multiple vaginal examinations (VEs), assisted vaginal delivery, maternal diabetes mellitus, preterm birth, post-term birth, intrauterine pressure catheter (IUPC) use, and fetal scalp electrode (FECG) use (Chen, 2019; Olsen et al., 2010). Risk of endometritis and other infectious morbidities decrease with the implementation of a surgical care bundle—that includes vaginal preparation—and standardized staff education (Duff, 2019; Felder et al., 2019; Kawakita & Umans, 2019; La Rosa et al., 2018; Martin et al., 2018; Money et al., 2018; Rauk, 2010). Care bundles, such as enhanced recovery after surgery (ERAS), are a combination of evidence-informed and standardized interventions, which—when used “collectively and reliably” (Institute for Healthcare Improvement, n.d., para. 1)—yield more enhanced patient outcomes compared to any single intervention (Polit & Beck, 2017). 1.1.2 Vaginal preparation. Vaginal preparation with antiseptic solutions has traditionally been used prior to gynecologic procedures such as hysteroscopies and vaginal or 3  abdominal hysterectomies (Abbas et al., 2018; Al-Niaimi et al., 2016; Eason et al., 2004; Eason et al., 1997; Kjølhede et al., 2011; Steiner & Strand, 2017). While vaginal preparation techniques and procedural steps were not discussed in detail, vaginal preparation has been associated with decreased infectious morbidities such as febrile morbidity, vaginal bacterial counts, surgical site infections, vaginal cuff infections, abdominal infections, pelvic infections, and urinary tract infections (Abbas et al., 2018; Eason et al., 2004; Kjølhede et al., 2011). Adverse effects of vaginal preparation with antiseptic solutions included symptoms of vaginal irritation such as burning, itchiness, dryness, pain, or soreness (Abbas et al., 2018; Al-Niaimi et al., 2016; Eason et al., 1997). However, prevalence of vaginal irritation was shown to be uncommon (Al-Niaimi et al., 2016). 1.1.3 Antiseptic solutions. Antiseptic solutions most commonly used in presurgical procedures such as skin—vaginal and abdominal—preparation include povidone-iodine and chlorhexidine (Culligan et al., 2005; Elshamy et al., 2020; Hadiati et al., 2018; Kunkle et al., 2015; Lee, 2019; Springel et al., 2017; Tolcher et al., 2019; Tuuli et al., 2016; Zuarez-Easton et al., 2017). Both iodine- and chlorhexidine-based solutions have been shown to reduce bacterial counts; however, whether one is more effective than the other remains unclear (Culligan et al., 2005; Elshamy et al., 2020; Kunkle et al., 2015; Springel et al., 2017; Tolcher et al., 2019; Tuuli et al., 2016). 1.1.4 Clinical practice guideline (CPG). CPGs are systematic evidence-informed statements that are intended to aid healthcare providers (HCPs) to make informed decisions about patient care (Institute of Medicine, 1990, 2011). As evidence-informed practice continues to advance, it is essential to translate and disseminate the ever-growing body of knowledge 4  produced by research. CPGs analyze, synthesize, and translate empirical evidence and, thus, can be the bridge between research and clinical practice (Polit & Beck, 2017). CPGs are used to guide decisions regarding diagnoses and therapeutic procedures (Eccles et al., 2012; Polit & Beck, 2017). They are used to guide and standardize patient care, thereby reducing inefficient use of resources and variation in practice among HCPs, which can negatively impact patient outcomes (Eccles et al., 2012; Kryworuchko et al., 2009; Mills et al., 2012; Murad, 2017). CPGs are derived from systematic reviews; however, they are often necessity-driven—that is, they are driven by the necessity to “guide clinical practice” (Polit & Beck, 2017, p. 28) rather than to synthesize and disseminate empirical knowledge. Therefore, although the available evidence may be suboptimal in quality or is limited, CPGs are still created based on the need for evidence-informed clinical practice. However, CPGs based on discretionary, or weak, recommendations require HCPs to exercise caution and use their clinical judgment when applying the CPG to clinical change (Murad, 2017). Though CPGs are meant to guide patient care, they are not intended to be prescriptive or be utilized as definitive manuals (Hollon et al., 2014). Thus, HCPs must use their clinical judgment and consider the individual context when consulting and adapting CPGs to make clinical decisions. 1.1.5 Trauma- and violence-informed care (TVIC). TVIC is a philosophical and practical approach that assumes that all individuals have experienced trauma and that violence is ongoing (Browne et al., 2015). Women who have experienced trauma and violence—including intimate partner violence and adverse childhood events such as sexual abuse—are at increased risk for post-traumatic stress disorder, depression, substance use issues, perinatal loss, placental abruption, antepartum hemorrhage, fear of childbirth, and decreased mother-infant bonding and attachment (Alhusen et al., 2015; Barrios et al., 2015; Kita et al., 2016; Moghaddam Hossieni et 5  al., 2017). However, patients may be hesitant to disclose previous or ongoing trauma and violence, as it is a sensitive topic. Therefore, it is imperative that HCPs assume that all patients have experienced trauma and violence and take measures to avoid re-traumatization such as thoroughly explaining procedures to patients and obtaining patient consent prior to all procedures. TVIC prioritizes and ensures patient safety, choice, and collaboration (Browne et al., 2015). Patients are more likely to trust and collaborate with HCPs if they feel that their HCPs care about them and not simply caring for them (Berg & Danielson, 2007). Moreover, shared decision-making allows patients to share their values and preferences while being informed about the benefits and risks of necessary interventions (Moore, 2016). Therefore, demonstrating empathy and collaboration with patients are crucial. Furthermore, the risk for trauma further increases in certain populations such as Indigenous people, who have historically experienced oppression due to colonialism (Browne et al., 2016). Thus, collaboration with patients removes patriarchal hierarchies that have historically dictated interactions between patients and HCPs as well as between different cultures.  1.2 Significance of the Issue 1.2.1 Personal significance. Obstetric nurses at BC Women’s Hospital and Health Centre (BCW) have been performing vaginal preparation for all women undergoing CS since circa 2012 (J. Lyons, personal communication, October 4, 2019). However, some nurses have admitted to hastily performing vaginal preparation, as they deemed the procedure irrelevant or questioned its efficacy. Furthermore, while speaking with obstetric nurses who work in other health authorities or have worked in other provinces, many stated they have never heard of the procedure before. This initially piqued my interest, and I decided to learn more about the 6  procedure. Upon investigation, I found that there currently is no policy or CPG on vaginal preparation (Provincial Health Services Authority, 2018; The Society of Obstetricians and Gynaecologists of Canada, n.d.). 1.2.2 Clinical significance. Current evidence suggests that vaginal preparation with antiseptic solutions prior to CS may reduce the risk of post-cesarean infectious morbidities in women who were in labour and/or whose membranes ruptured prior to CS (Asghania et al., 2011; Caissutti et al., 2017; Felder et al., 2019; Göymen et al., 2017; Haas et al., 2010, 2018; Memon et al., 2011; Starr et al., 2005; Yildirim et al., 2012). However, knowledge about the efficacy of vaginal preparation in women undergoing elective CS with intact membranes and/or without signs of labour in reducing the risk of post-cesarean infectious morbidities is not well-understood (Caissutti et al., 2017; Felder et al., 2019; Haas et al., 2018). Therefore, the review of literature with the goal of creation of a CPG may help to clarify the use of pre-cesarean vaginal preparation by identifying the group of women who may benefit from the procedure. 1.3 Purpose of Project The purpose of this project is to create a CPG for HCPs based on the review of the literature on vaginal preparation. Research generates new knowledge with the intent of uptake by knowledge-users (Canadian Institutes of Health Research [CIHR], 2016). Knowledge translation (KT) involves synthesizing, disseminating, exchanging, and ethically applying “knowledge to improve the health of Canadians, provide more effective health services and products and strengthen the health care system” (CIHR, 2016, para. 4). Therefore, the results of the initial literature review for this SPAR will inform the development of a CPG for the use of pre-cesarean vaginal preparation. 7  In accordance with KT, CPGs—as previously mentioned—aim to analyze, synthesize, and translate empirical evidence to guide HCPs’ clinical practice. Thus, CPGs are a practical, convenient, and easily accessible method for HCPs in the clinical setting to access up-to-date evidence—especially if they do not have the time to, or are uncomfortable with, reading, interpreting, and synthesizing findings from journal articles. The CPG developed for this SPAR project will include a background (to educate HCPs about the rationale for vaginal preparation), eligibility criteria, a step-by-step procedure, exclusion criteria, and required documentation. The hope is that this SPAR project will help inform obstetric HCPs’ current practice at BCW and possibly at other sites across the Lower Mainland and Canada.   8  Chapter 2: Methodology 2.1 Researchable question The researchable (PICO) question that guided the literature search was: In all women undergoing CS, is vaginal preparation with antiseptic solutions versus no vaginal preparation prior to cesarean birth more effective in reducing the risk of infection? The population of interest (P) was women undergoing CS. The nature of CS was not specified to include primary, repeated, scheduled, and urgent CS. The intervention (I) was vaginal preparation with antiseptic solutions, and the comparison (C) was no vaginal preparation. The type of antiseptic solution was not specified to include povidone-iodine and chlorhexidine, among other types of antiseptic solution. The outcome (O) was reduced risk of infection. The type of infection was not specified to include endometritis and abdominal wound infections, among other types of infection. 2.2 Systematic Search 2.2.1 Systematic search process.  The systematic literature search was guided by the researchable question stated above. The database CINAHL (Cumulative Index to Nursing and Allied Health Literature) was used on January 21, 2020 and databases MEDLINE (Ovid), EMBASE (Ovid), and TRIP (Turning Research Into Practice) were used on January 24, 2020 to conduct a systematic literature search of the researchable question. Upon consultation with the UBC Nursing Reference Librarian, subject headings and keywords included were: cesarean section, cesarean birth, cesarean delivery (as well as variations of cesarean including caesarean, caesarian and cesarian); abdominal birth and abdominal delivery; postcesarean section, postcesarean delivery, and postcesarean birth (as well as variations of postcesarean including post-cesarean, post cesarean, postcaesarean, post-9  caesarean, post caesarean, postcaesarian, post-caesarian post caesarian, postcesarian, post-cesarian, post cesarean, post c-section, and post c section); vaginal preparation, vaginal cleansing, vaginal wash, vaginal washing, and vaginal antisepsis; surgical skin preparation, preoperative skin preparation, and preoperative care; and surgical wound infection, surgical infection, infection, endometritis, and endometrial diseases. A more detailed search strategy is outlined in Appendix A. Boolean operators AND, OR, adj3, and N3 were used to combine the subject headings and keywords to conduct the search. The systematic search was narrowed by language and publication type. For the purpose of this project, studies that met all the inclusion criteria were considered: studies about human subjects; studies published in academic journals; studies published in the English language; studies that addressed all the components of the researchable question; and studies that were systematic reviews, high-quality controlled trials (or quasi-experimental studies), or randomized controlled trials (RCTs). Only systematic reviews, high-quality controlled trials, and RCTs were included to yield rigorous and scientifically-sound studies. No limit was placed on publication date due to the relatively limited number of relevant studies. The search generated studies published between 1998 through 2019. The final search yielded 354 articles (see Appendix A). An additional 11 articles were identified using ancestry and descendancy approaches. In systematic literature searches, ancestry approach is the use of citations or references from relevant articles to search for ascendants, or earlier articles related to the topic of interest (Polit & Beck, 2017). Conversely, descendancy approach is the use of citation indexes of early articles to search for descendants, or more recent articles related to the topic of interest (Polit & Beck, 2017). 10  2.2.2 Literature selection process. Of the 365 articles, 125 were excluded for the following reasons: were duplicates (n=89), were not systematic reviews, RCTs, or high-quality controlled trials (n=18), was a study in progress (n=1), was about non-human subjects (n=1), were no longer available due to being replaced by an updated edition (n=9), and were not available through UBC Summons (n=7). Upon reading the 240 remaining articles that met the inclusion criteria, 229 articles were excluded for the following reasons: included vaginal preparation in vaginal births (n=1); were about surgical technique, postoperative care, or other procedures (n=64), were exclusively about abdominal and back skin preparation, or did not specify vaginal preparation (n=19), were about prophylactic antibiotics (n=67); were exclusively about endometritis or other endometrial or pelvic conditions (n=10); were exclusively about CS complications or did not include endometrial conditions (n=40); the primary objective was not about the efficacy of pre-cesarean vaginal preparation (n=14); was about perineal toilets (n=1);  were about skin microbiology or infectious diseases (n=12); and was about mHealth (n=1). The final 11 articles (Ahmed et al., 2017; Aref, 2019; Asghania et al., 2011; Caissutti et al., 2017; Guzman et al., 2002; Haas et al., 2010, 2018; Memon et al., 2011; Reid et al., 2001; Starr et al., 2005; Yildirim et al., 2012)—henceforth referred to as the studies—met all the inclusion criteria and reflected the knowledge to be synthesized for this project. A modified PRISMA 2009 flow diagram, depicted in Figure 1 below, was used to illustrate the literature selection process (Moher et al., 2009).   11  Figure 1: Modified PRISMA 2009 flow diagram     Articles identified through electronic database searching (n=354)  CINAHL (n=47) MEDLINE (n=85) EMBASE (n=86) TRIP (n=136) Additional articles identified through ancestry and descendancy approaches (n=11) Articles after duplicates removed (n=276) Articles screened (n=276) Articles excluded (n=36)  Qualitative study, commentary, abstract, appraisal, poster presentation, practice bulletin, protocol, case study (n=18) Study in progress (n=1) Non-human subjects (n=1) No longer available d/t replaced by updated edition (n=9) Not available through UBC Summons (n=7) Full-text articles assessed for eligibility (n=240) Full-text articles excluded (n=228)  Vaginal preparation in vaginal birth included (n=1) Focus on surgical technique, postoperative care, and other procedures (n=64) Focus on abdominal or back skin preparation or did not specify vaginal preparation (n=19) Focus on prophylactic antibiotics (n=67) Focus on endometritis or endometrial/pelvic conditions (n=10) Focus on CS complications or did not include endometritis (n=40) Primary objective not about efficacy of vaginal preparation (n=14) Focus on perineal toilet (n=1) Focus on skin microbiology or infectious diseases (n=12) Focus on mHealth (n=1) Total number of articles included (n=12) 12  2.2.3 Critical appraisal process. The Joanna Briggs Institute (2018) critical appraisal tools were utilized to critically appraise the 12 studies because they included clear instructional guides for using each type of tool. Specifically, the JBI Appraisal Checklist for Randomized Controlled Trials, the JBI Appraisal Checklist for Systematic Quasi-Experimental Studies (non-randomized experimental studies), the JBI Appraisal Checklist for Case Control Studies, and the JBI Appraisal Checklist for Systematic Reviews were used to assess for possible biases and the quality of the study (Joanna Briggs Institute, 2018). 2.2.4 Synthesis processes and procedures. To synthesize the literature, Garrard’s (2017) Matrix Method—a structured method of organizing and reviewing scientific literature—was used. All 12 studies were quantitative; therefore, one matrix was created on an Excel spreadsheet. The studies were listed chronologically from oldest to most recent to see the progression of the topic in the literature (Garrard, 2017). The 11 columns created were: author(s), year; objective; method (including study design, sample, inclusion criteria, exclusion criteria, and study setting); intervention and control (including type of antiseptic solution, length of vaginal preparation), number of swabs used for vaginal preparation, method; use of prophylactic antibiotics; outcomes and definitions of outcomes; data collection and analysis; results; strengths and limitations; recommendations; and comments. These columns reflected the studies’ key components with which to compare and contrast. 2.3 Theoretical Perspectives Bayes’ theorem for judgment—a positivist theory, also referred to as expected utility theory, derived from normative theory of judgment and decision-making (JDM)—was used to guide this project (Shaban, 2005). Risk assessment and interpretation are the central components of JDM; thus, all possible risks—in addition to benefits—must be explored and analyzed prior to 13  decision-making (Shaban, 2005). For example, to determine if vaginal preparation is required, the individual woman's risk of infectious morbidity must be explored. Such risks include: the signs of labour (i.e., regular uterine activity and cervical dilation and effacement), the duration and characteristics of ruptured membranes (i.e., clear, blood-stained, or meconium-stained), the presence of active infections, clinical manifestations of evolving infections, or the classification of CS (i.e., urgent CS). In addition, the risks associated with the type of antiseptic solution used for vaginal preparation must be explored, such as side effects and contraindications. Therefore, the theorem for judgment provided a framework by which the CPG was created. Moreover, according to Bayes, the decision-making process may be guided by the use of decision aids such as CPGs or decision trees (Shaban, 2005). While empirical evidence is important to inform decision-making, it is equally important to consider alternative types of evidence such as patient preference and clinical expertise, as per evidence-based nursing, or evidence-informed decision-making (Canadian Nurses Association, 2010). The inclusion of patients in the decision-making process honours their autonomy, including their right to refuse, and considers their individual context to help inform decision-making. Thus, this theoretical perspective informed the creation of the CPG, highlighting the importance of alternative types of evidence in decision-making. In addition, this theoretical perspective guided the discussion of implications of the CPG on nursing practice and on patients. This chapter has identified the researchable question that will guide the literature review for this project, outlined the methodology for conducting the literature review, and identified theoretical underpinning that will guide the discussion of the findings. The next chapter will describe and critically analyze the findings of the literature review.  14  Chapter 3: Findings 3.1 Key Characteristics of Main Findings 3.1.1 Types of study design and location of study. The majority of the studies included in the literature synthesis were primary studies, most of which were RCTs. Primary studies are original research studies published in academic journals (Polit & Beck, 2017). The findings of primary studies are often used as the data in systematic reviews (Polit & Beck, 2017). Of the 11 included studies, seven were RCTs (Ahmed et al., 2017; Aref, 2019; Guzman et al., 2002; Haas et al., 2010; Reid et al., 2001; Starr et al., 2005; Yildirim et al., 2012), one was a quasi-experimental study (Asghania et al., 2011), one was a case-control study (Memon et al., 2011), and two were systematic reviews (Caissutti et al., 2017; Haas et al., 2018). Though case-control studies were not identified in the inclusion criteria, Memon et al.’s (2011) case-control study was included in the literature synthesis because it was conducted using a similar design to an RCT. The majority of the studies were conducted in the United States of America (USA) and the Middle East. Four studies were conducted in the USA (Guzman et al., 2002; Haas et al., 2010; Reid et al., 2001; Starr et al., 2005), one in Iran (Asghania et al., 2011), one in Pakistan (Memon et al., 2011), one in Turkey (Yildirim et al., 2012), one in Egypt (Ahmed et al., 2017), and one in Saudi Arabia (Aref, 2019). Apart from the studies reviewed in this project, the two systematic reviews also included three primary studies conducted in the USA, one in Thailand, two in Egypt, one in Bangladesh, one in Pakistan, and one in Turkey (Caissutti et al., 2017; Haas et al., 2018). 3.1.2 Sample description. This subsection describes the baseline characteristics of the sample of the primary studies and systematic reviews.  15  3.1.2.1 Primary studies. The recruitment period of the primary studies ranged from six months to two-and-a-half years. The total number of participants recruited in the primary studies ranged from 160 to 670. All 3,042 women were pregnant at the time of enrollment of the studies. The average age of the participants across the studies was 27 years of age; the majority of the participants were over 20 years of age. While both nulliparous and multiparous women were included in the studies, the majority of the women were multiparous. The average parity across the studies was one to two. The majority of the pregnancies were term—that is, gestational age across the studies was typically at or greater than 37 weeks. The majority of the participants had intact membranes at the time of CS and received less than five VEs prior to CS. 3.1.2.2 Systematic reviews. Caissutti et al. (2017) selected primary studies from inception to January 2017 and Haas et al. (2018) included primary studies from inception to July 2017. Caissutti et al. (2017) analyzed a total of 4,744 participants while Haas et al. (2018) analyzed a 3,403. The baseline demographic characteristics are the same as those outlined in subsection 3.1.2.1. 3.1.3 Inclusion and exclusion criteria. This subsection outlines the inclusion and exclusion criteria for primary studies and systematic reviews. 3.1.3.1 Primary studies. Inclusion criteria for the primary studies included all women who were undergoing CS. Two studies specified term singleton pregnancy and elective cesarean delivery (Ahmed et al., 2017; Aref, 2019) and two studies specified that the women must be at least 18 years of age and capable of giving informed consent (Haas et al., 2010; Memon et al., 2011). The remaining studies included both elective and unplanned cesarean delivery. Exclusion criteria for all studies included emergent CS, which are CS performed emergently due to maternal or fetal factors such as placental abruption, prolonged deceleration, 16  or eclampsia; placenta previa; and allergy or hypersensitivity to povidone-iodine or iodine. Other identified exclusion criteria included: allergy to shellfish (Reid et al., 2001), history of or active genital herpes (Asghania et al., 2011; Reid et al., 2001), positive Group B Streptococcus (GBS) or bacterial vaginosis culture within two weeks prior to delivery (Aref, 2019), presence of chorioamnionitis (Asghania et al., 2011; Starr et al., 2005), planned cesarean hysterectomy (Haas et al., 2010), fetal distress (Asghania et al., 2011), abnormal antenatal vaginal discharge (Asghania et al., 2011), premature rupture of membranes (Ahmed et al., 2017), umbilical cord prolapse (Yildirim et al., 2012), and immunocompromised status due to long-term steroid therapy or diabetes mellitus (Ahmed et al., 2017; Aref, 2019). 3.1.3.2 Systematic reviews. Inclusion criteria for the systematic reviews included RCTs that assessed the effect of vaginal preparation using any type of antiseptic solution (compared to a control—either a placebo or standard care) on post-cesarean infectious morbidities. Caissutti et al. (2017) also specified that vaginal preparation must have been performed within an hour of CS. Haas et al. (2018) also included quasi-randomized and cluster-randomized trials.  Exclusion criteria included studies that included vaginal preparation in vaginal deliveries and studies that did not specify the use of prophylactic antibiotics. Caissutti et al. (2017) also excluded studies that did not include the outcomes of interest (i.e., infectious morbidities). 3.1.4 Interventions and controls. This subsection details the interventions and controls examined in the primary studies and the systematic reviews. 3.1.4.1 Type of antiseptic solution. The majority of the primary studies examined vaginal preparation with povidone-iodine of varying concentration (Aref, 2019; Asghania et al., 2011; Guzman et al., 2002; Haas et al., 2010; Memon et al., 2011; Reid et al., 2001; Starr et al., 2005; Yildirim et al., 2012). Of these studies, one used povidone-iodine 1% (Haas et al., 2010), four 17  used povidone-iodine 10% (Aref, 2019; Asghania et al., 2011; Memon et al., 2011; Reid et al., 2001), and three did not specify concentration (Guzman et al., 2002; Starr et al., 2005; Yildirim et al., 2012). One study examined vaginal preparation with chlorhexidine acetate 0.25% (Ahmed et al., 2017). The systematic reviews (Caissutti et al., 2017; Haas et al., 2018) evaluated studies that used povidone-iodine with concentrations of 1%, 5%, and 10%, and chlorhexidine diacetate with concentrations of 0.2%, 0.25%, and 0.4%. Caissutti et al. (2017) also evaluated studies that used metronidazole 5% vaginal gel and cetrimide. Haas et al. (2018) also evaluated studies that used benzalkonium chloride. 3.1.4.2 Method of vaginal preparation. Across the studies, vaginal preparation was most commonly performed by using two or three sponge sticks or sterile gauzes—saturated with an antiseptic solution—to clean the vaginal cavity in a circular motion from the vaginal apex to the introitus for at least 30 seconds. In the study conducted by Guzman et al. (2002), vaginal preparation was performed by holding a sponge stick saturated with povidone-iodine in the vaginal cavity (at the vaginal apex) for three minutes. Three studies stated vaginal preparation was performed over 30 seconds (Asghania et al., 2011; Starr et al., 2005; Yildirim et al., 2012), four over one minute (Ahmed et al., 2017; Aref, 2019; Haas et al., 2010; Memon et al., 2011), and one did not specify the duration of vaginal preparation (Reid et al., 2001). Five studies specified using sterile gauzes (Ahmed et al., 2017; Aref, 2019; Asghania et al., 2011; Memon et al., 2011; Reid et al., 2001). Of these studies, two used two sterile gauzes (Aref, 2019; Asghania et al., 2011), while three used three sterile gauzes (Ahmed et al., 2017; Memon et al., 2011; Reid et al., 2001). Four reported using sponge sticks (Guzman et al., 2002; 18  Haas et al., 2010; Starr et al., 2005; Yildirim et al., 2012), of which one used one sponge stick (Guzman et al., 2002), two used two sponge sticks (Starr et al., 2005; Yildirim et al., 2012), and one used three sponge sticks (Haas et al., 2010).  The scrub nurse performed vaginal preparation in three studies (Ahmed et al., 2017; Aref, 2019; Guzman et al., 2002), the physician resident in one study (Reid et al., 2001), a “trained operation room personnel” (Haas et al., 2010, p. 310.e2) in one study, and four studies did not specify who performed the procedure (Asghania et al., 2011; Memon et al., 2011; Starr et al., 2005; Yildirim et al., 2012). Vaginal preparation was typically done after Foley catheter insertion once the women received adequate anesthesia (Ahmed et al., 2017; Aref, 2019; Haas et al., 2010; Memon et al., 2011; Reid et al., 2001). Three studies reported that vaginal preparation was performed at the same time as the abdominal preparation (Ahmed et al., 2017; Starr et al., 2005; Yildirim et al., 2012). Standard abdominal preparation was performed in all the studies. Prophylactic antibiotics were administered prior to skin incision in three studies (Ahmed et al., 2017; Aref, 2019; Asghania et al., 2011), during the CS in two studies (Memon et al., 2011; Yildirim et al., 2012), and at the time of umbilical cord clamping in one study (Starr et al., 2005). Two sources reported postpartum prophylactic antibiotic administration (Asghania et al., 2011; Caissutti et al., 2017). Haas et al. (2010) did not specify the timing of prophylactic antibiotic administration and two studies did not specify whether prophylactic antibiotics were administered (Guzman et al., 2002; Reid et al., 2001). 3.1.4.3 Types of controls. The majority of the primary studies used standard care—that is, no vaginal preparation—as the control (Ahmed et al., 2017; Aref, 2019; Asghania et al., 2011; 19  Haas et al., 2010; Memon et al., 2011; Reid et al., 2001; Starr et al., 2005; Yildirim et al., 2012). Guzman et al. (2002) used vaginal preparation with sterile normal saline as a control. The systematic reviews included vaginal preparation with a placebo, typically normal saline, or no vaginal preparation as the control (Caissutti et al., 2017; Haas et al., 2018). 3.1.5 Outcome measures. Endometritis was the primary outcome of interest in all studies. Secondary outcomes across the studies included wound infection (or wound complication) and fever (or febrile morbidity). Guzman et al. (2002) also included cellulitis, which was defined as “advancing erythema around the incision” (p. 207). All sources had similar definitions for endometritis, wound infection, and fever (see Appendix B). Caissutti et al. (2017) did not create operational definitions for outcomes; rather, they referred to the definitions used by the primary sources. Some studies specified that other sources of infection that contributed to an elevation in temperature—such as atelectasis, pneumonia, breast engorgement, or urinary tract infection (UTI)—were not considered febrile morbidities (Ahmed et al., 2017; Aref, 2019; Asghania et al., 2011).    3.1.6 Source of funding. Three studies were funded internally (Haas et al., 2010, 2018; Starr et al., 2005), while two studies declared they were unfunded (Ahmed et al., 2017; Aref, 2019). The remaining studies did not report any source of funding. 3.1.7 Declaration of interest. Five studies declared no conflicts of interest (Ahmed et al., 2017; Aref, 2019; Caissutti et al., 2017; Haas et al., 2018; Yildirim et al., 2012), while the remaining studies did not report any declaration of interest. 3.2 Synthesis of Main Findings Generally, there was no statistically significant difference in baseline demographic characteristics between the intervention and control groups across the studies. Asghania et al. 20  (2011) reported that while there was no statistically significant difference in some characteristics (including maternal age, occupation, maternal weight, parity, anemia, diabetes, genital infection, history of previous CS, and history of previous abortion) between the two groups, there were statistically significance differences in other characteristics (including gestational age, UTI, duration of surgery, duration of labour, duration of rupture of membranes, and presence of meconium). Overall, the studies concluded that women who did receive vaginal preparation with an antiseptic solution were less likely to develop post-cesarean endometritis when compared to women who did not receive vaginal preparation. Only one study reported that vaginal preparation with povidone-iodine did not reduce the incidence of endometritis (Reid et al., 2001). However, the authors also included cases of clinical endometritis, which did not require a temperature greater or equal to 38ºC—an important criteria for endometritis (Reid et al., 2001). Ten studies determined that pre-cesarean vaginal preparation with either povidone-iodine or chlorhexidine reduced the incidence of endometritis (Ahmed et al., 2017; Aref, 2019; Asghania et al., 2011; Caissutti et al., 2017; Guzman et al., 2002; Haas et al., 2010, 2018; Memon et al., 2011; Starr et al., 2005; Yildirim et al., 2012). Of these ten studies: one found a reduction, but the results were not statistically significant (Haas et al., 2010); two found a statistically significant reduction only in women who were in labour at the time of CS or whose membranes were ruptured (Caissutti et al., 2017; Yildirim et al., 2012); two found a statistically significant reduction in all women, but especially those who were in labour at the time of CS or whose membranes were ruptured (Ahmed et al., 2017; Haas et al., 2018; Memon et al., 2011); and three found a statistically significant reduction in endometritis in all women (Asghania et al., 2011; Guzman et al., 2002; Starr et al., 2005). Asghania et al. (2011) noted that vaginal preparation did 21  not drastically reduce the incidence of endometritis; however, the difference was statistically significant. Haas et al. (2018) suggested using caution to interpret the subgroup analysis, as there was a relatively small number of women who were in labour at the time of CS or whose membranes were ruptured. Nevertheless, Haas et al. (2018) recommended the implementation of vaginal preparation in all women undergoing CS due to its capacity to reduce the incidence of endometritis. There were mixed findings for the relationship between vaginal preparation with antiseptic solutions and wound infection and fever. Four studies concluded that there was no statistically significant reduction in the incidence of composite febrile morbidity, fever, and wound infection (Ahmed et al., 2017; Aref, 2019; Starr et al., 2005; Yildirim et al., 2012). Three studies concluded that vaginal preparation with antiseptic solutions decreases the incidence of composite infectious morbidities—two stated that the reduction was statistically significant (Ahmed et al., 2017; Memon et al., 2011), while one stated that the reduction was not statistically significant (Haas et al., 2010). 3.3 Summary of Critical Appraisal 3.3.1 Strengths. Most of the primary studies (Ahmed et al., 2017; Aref, 2019; Guzman et al., 2002; Haas et al., 2010; Reid et al., 2001; Starr et al., 2005; Yildirim et al., 2012) and the majority of the studies included in the systematic reviews were RCTs. RCTs produce the second-highest level of evidence—next to systematic reviews—for intervention research (or therapy or treatment research), which focuses on the evaluation of interventions (Polit & Beck, 2017). It is appropriate that most of the studies were RCTs because the researchable question that guided this project focuses on the evaluation of an intervention (i.e., vaginal preparation). 22  Quasi-experimental studies, or controlled trials without randomization, and case studies are in the lower tiers of the evidence hierarchy and thus are considered lower-quality studies (Polit & Beck, 2017). However, the authors took measures to adjust for confounding variables and ensure that findings can be generalized. Like RCTs, quasi-experimental studies comprise interventions but lack randomization—also known as random allocation or random assignment—which “involves assigning participants to treatment conditions at random” (Polit & Beck, 2017, p. 188). The lack of randomization increases the risk of outcomes being affected by confounding variables and decreases the likelihood of generalized findings (Polit & Beck, 2017). Thus, Asghania et al. (2011) used a logistic regression model to adjust for confounding variables by including confounding variables—such as duration of labour, rupture of membranes, and surgery; history of preterm pregnancy; and number of VEs—in the model as independent variables. Logistic regression analyzes the relationship between two or more independent variables and one dependent variable—in this case, vaginal preparation versus no vaginal preparation (independent variables) and endometritis (dependent variable).  Case-control studies are nonexperimental, or observational studies in which the independent variable is not manipulated (Polit & Beck, 2017). While labelled a case-control study, the methods used by Memon et al. (2011) resembled an RCT, whereby the authors used randomization to adjust for confounding variables. Seven additional studies reported the use of randomization (Ahmed et al., 2017; Aref, 2019; Asghania et al., 2011; Guzman et al., 2002; Haas et al., 2010; Reid et al., 2001; Starr et al., 2005). Both systematic reviews consulted the Cochrane Handbook for Systematic Reviews of Interventions to assess studies for biases, including selection bias, attrition bias, detection bias, reporting bias, performance bias, and other bias (Caissutti et al., 2017; Haas et al., 2018). 23  Caissutti et al. (2017) also performed Begg’s test and Egger’s test to assess for “potential publication biases” (p. 533). The overall risk of bias was low to moderate, suggesting that the authors in the included studies took measures to reduce the risk of bias and maintain internal validity (Caissutti et al., 2017; Haas et al., 2018).  While double-blinding— wherein participants and researchers are unaware of the group (intervention or control) to which the participants were assigned (Polit & Beck, 2017)—is the ideal in RCTs, only two studies were double-blinded (Ahmed et al., 2017; Asghania et al., 2011). In most studies, the outcome assessors were blinded, therefore, reducing the risk of detection bias (Ahmed et al., 2017; Aref, 2019; Asghania et al., 2011; Guzman et al., 2002; Haas et al., 2010; Memon et al., 2011; Reid et al., 2001; Starr et al., 2005). Guzman et al. (2002) stated that HCPs who cared for the participants postpartum were also blinded. Furthermore, while the Haas et al. (2010) study was included in the Haas et al. (2018) systematic review, the authors of the study did not assess the article to reduce the risk of bias. Haas et al. (2018) also reported that multiple authors collected and analyzed the data independently to reduce the risk of bias. This is important because bias can alter the collection, interpretation and analysis, and reporting of data (Polit & Beck, 2017). Therefore, taking measure to reduce the risk of bias ensures that all data remain objective and uncontaminated, and are included and reported. The studies were generally built upon previous research to address and account for limitations and gaps in the literature. Three studies established the operational definitions for all outcomes a priori (Haas et al., 2010; Memon et al., 2011; Reid et al., 2001), thereby reducing reporting bias. Six studies performed a power analysis to establish a minimum sample size for adequate power (Ahmed et al., 2017; Asghania et al., 2011; Guzman et al., 2002; Haas et al., 2010; Starr et al., 2005; Yildirim et al., 2012). Compared with smaller sample sizes, larger 24  sample sizes increase power, therefore decreasing the risk of a type II error, wherein the null hypothesis—stating there is no relationship between the variables investigated—is falsely accepted (Polit & Beck, 2017). To account for attrition, which can also increase the risk of a type II error, four studies used intention-to-treat analysis (Haas et al., 2010, 2018; Reid et al., 2001; Starr et al., 2005), in which the data from all participants are analyzed in the group to which they were randomly allotted, regardless of missing data or participant attrition (Polit & Beck, 2017). Furthermore, the systematic reviews appropriately combined the studies for analysis.  3.3.2 Limitations. While a power calculation was performed to determine the minimum sample size for an adequately powered study, many authors identified that the sample size was relatively small, increasing the risk of a type II error (Ahmed et al., 2017; Aref, 2019; Asghania et al., 2011; Guzman et al., 2002; Haas et al., 2010; Memon et al., 2011; Starr et al., 2005). One study attributed the small sample size to premature cessation of the trial due to difficulty in participation recruitment (Haas et al., 2010), while two studies attributed the small sample size to participant attrition (Ahmed et al., 2017; Starr et al., 2005). Moreover, Starr et al. (2005) explained that a significant amount of data was lost due to unavailability of patient information and hospital charts, and the exclusion of participants “due to violation of inclusion criteria” (Starr et al., 2005, p. 1026) such as vaginal delivery and diagnosis of intrapartum chorioamnionitis. The authors identified that the smaller sample size may have led to an overestimation of the effect of vaginal preparation on the outcomes (Ahmed et al., 2017; Haas et al., 2010; Starr et al., 2005).  There was a relatively high risk of bias in regards to blinding. The outcome assessors in the Yildirim et al. (2012) study were not blinded to participant allocation. The individuals who performed vaginal preparation in all of the primary studies were not blinded. Furthermore, most 25  of the studies did not specify that the participants were blinded (Aref, 2019; Guzman et al., 2002; Memon et al., 2011; Reid et al., 2001; Starr et al., 2005; Yildirim et al., 2012). While Haas et al. (2010) reported that the participants and the providers were not blinded to participant allocation, they were also not explicitly told of the group to which the participant belonged. The lack of blinding of the participants and the providers may have increased the risk of bias. However, it would have been challenging to blind those who performed vaginal preparation because the control for many studies was no vaginal preparation (i.e., standard care). Therefore, it may not have been feasible or possible to blind these individuals. Five studies reported having samples that were not representative of the population, threatening their external validity (Ahmed et al., 2017; Aref, 2019; Haas et al., 2010; Starr et al., 2005; Yildirim et al., 2012). Women who were in labour at the time of CS were underrepresented in three studies (Haas et al., 2010; Starr et al., 2005; Yildirim et al., 2012) and completely excluded in two studies (Ahmed et al., 2017; Aref, 2019). Haas et al. (2010) disclosed that women who were in labour at the time of CS were underrepresented because it was easier to obtain consent from women undergoing elective CS. Ahmed et al. (2017) chose to only include women who were undergoing elective CS due to the rise in international rates of CS. The systematic reviews noted that there was considerable variability in study implementation—such as diagnosis of endometritis, vaginal preparation techniques, antiseptic solution concentration, and timing of antibiotic administration—which could have affected the results (Caissutti et al., 2017; Haas et al., 2018). Caissutti et al. (2017) stated that the inclusion of a study about vaginal preparation with an antibiotic may have been a confounder and that the 26  exclusion of studies that included vaginal preparation in both vaginal and cesarean births "without stratifying data for mode of delivery" (p. 536) could have affected their results.  The quasi-experimental study lacked randomization (Asghania et al., 2011). The lack of randomization may result in confounding variables that are uncontrolled and, thus, threatening internal validity (Polit & Beck, 2017). However, as previously discussed, the authors took measures to adjust for the confounding variables. While Memon et al.'s (2011) study was labelled a case-control study, its design was analogous to an RCT; furthermore, the authors also did not list any limitations. Reid et al. (2001) included women who did not speak English to increase external validity. However, measures taken to ensure accurate translation was not outlined; thus, whether consent was truly informed is unclear. Guzman et al. (2002) also did not provide details of the process of randomization or data collection and analysis. Moreover, Aref's (2019) study—including the results and the way in which the article was written—was nearly identical to that of the Ahmed et al.'s (2017) study, which Aref co-authored. Caution may be warranted when interpreting the results. Overall, the findings suggest that vaginal preparation with either povidone-iodine or chlorhexidine prior to CS may reduce the risk of postpartum endometritis, especially in women who had ruptured membranes or were in labour at the time of CS. The next chapter will discuss the implications of the findings, outline a clinical practice guideline for vaginal preparation, and provide recommendations for clinical practice and future research.   27  Chapter 4: Discussion and Recommendations 4.1 Discussion This section will discuss the findings from the literature synthesis in the previous chapter to reveal knowledge gaps and identify the strengths and limitations of this project. 4.1.1 Gaps in literature. Maternal factors that increase a woman’s risk for developing postpartum endometritis include infections such as active genital herpes simplex (HSV), human immunodeficiency virus (HIV), or the presence of Group B Streptococcus (GBS) or chorioamnionitis (Chen, 2019; Duff, 2019; Olsen et al., 2010; Safrai et al., 2017; Zuarez-Easton et al., 2017). Other factors include prolonged rupture of membranes, meconium-stained amniotic fluid, manual removal of the placenta, prolonged labour, preterm birth, post-term birth, multiple VEs, maternal diabetes mellitus, preeclampsia, anemia, long-term steroid therapy use, increased body mass index (BMI), amnioinfusion, and use of an IUPC or FECG (Chen, 2019; Duff, 2019; Olsen et al., 2010; Safrai et al., 2017; Shea & Soper, 2019; Zuarez-Easton et al., 2017). The findings of the literature synthesis suggest that vaginal preparation with antiseptic solutions—namely, povidone-iodine and chlorhexidine—prior to cesarean birth reduces the incidence of postpartum endometritis, particularly in women who had ruptured membranes or were in labour at the time of CS. However, vaginal preparation with povidone-iodine and chlorhexidine did not reduce the incidence of overall composite febrile or infectious morbidities. All possible risks and benefits must be considered and calculated before making a clinical decision, as per Bayes’ theorem for judgment (Shaban, 2005). Although the majority of the studies in this project examined vaginal preparation with povidone-iodine (Aref, 2019; Asghania et al., 2011; Caissutti et al., 2017; Guzman et al., 2002; Haas et al., 2010, 2018; Memon et al., 2011; Reid et al., 2001; Starr et al., 2005; Yildirim et al., 28  2012), some assessed vaginal preparation with chlorhexidine acetate (Ahmed et al., 2017) or chlorhexidine diacetate (Caissutti et al., 2017; Haas et al., 2018). Currently, recommendations from the American College of Obstetricians and Gynecologists (ACOG) state that while povidone-iodine is the only antiseptic that has been approved for vaginal preparation by the Food and Drug Administration (FDA), 4% chlorhexidine gluconate may be used off-label as an appropriate alternative (Lee, 2019; Money et al., 2018; Shea & Soper, 2019). Chlorhexidine gluconate is not affected by vaginal pH, is associated with decreased vaginal symptoms, and “is not readily absorbed by mucous membranes” (Al-Niaimi et al., 2016, p. 996). Nevertheless, povidone-iodine is currently the only FDA-approved antiseptic solution for vaginal preparation and, thus, is most widely utilized. No adverse effects of vaginal preparation with antiseptic solutions were noted; however, adverse effects were not explicitly assessed in most of the studies. Moreover, the concentration of antiseptic solutions and the duration of vaginal preparation varied between the studies, which may have influenced vaginal symptoms. Previous research on vaginal preparation with povidone-iodine and chlorhexidine have found that the incidence of mild vaginal symptoms (such as burning, itching, soreness, swelling, and dryness) was low, while the incidence of moderate vaginal symptoms were rare (Abbas et al., 2018; Al-Niaimi et al., 2016). The majority of the women who received vaginal preparation reported no adverse effects of povidone-iodine or chlorhexidine gluconate—that is, they did not experience vaginal symptoms (Abbas et al., 2018; Al-Niaimi et al., 2016). There is little research on the effect of vaginal preparation on neonates. Ahmed et al. (2017) identified “the lack of follow-up to neonatal outcomes” (p. 1487) as a limitation of their study. A recent systematic review on pre-cesarean skin (abdominal and vaginal) preparation 29  revealed that the effect of antiseptic solutions on neonates was not reported, though one study disclosed that iodine was found in the umbilical cord blood (Hadiati et al., 2018). Furthermore, most research focused on term pregnancies; thus, little is known about the safety and efficacy of vaginal preparation in preterm pregnancies. Recently, there has been growing interest in the impact of the type of birth (vaginal versus cesarean) on the neonatal intestinal microbiome. Current evidence states that cesarean births reduce the diversity of neonatal intestinal microbiome and are associated with intestinal microbiome dysbiosis, or imbalanced intestinal microbiome (Azad et al., 2013; Lee et al., 2016; Nagpal & Yamashiro, 2018; Rutayisire, Huang, Liu, & Tao, 2016; Salas Garcia, Yee, Gilbert, & Dsouza, 2018). Microbiome dysbiosis and reduced microbiome diversity have been associated with obesity, type 1 diabetes mellitus, asthma, celiac disease, atopy, allergies, and rhinitis (Ajslev et al., 2011; Arboleya et al., 2015; Francino, 2018; van Nimwegen et al., 2011). Moreover, exposure to perinatal antibiotics has also been associated with reduced intestinal microbiome diversity (Arboleya et al., 2015). Similarly, there is a potential that vaginal preparation with antiseptic solutions may further impact the neonatal intestinal microbiome, particularly in women with ruptured membranes. 4.1.2 Strengths. In the systematic search, possible subject headings and keywords were identified using reverse engineering, and Boolean operators—AND, OR, adj3, and N3— and the truncation symbol were used to maximize the number of eligible studies. The ancestry and descendancy approaches were used, as well as handsearching reference lists of the selected articles, to increase the number of relevant studies. This project primarily reviewed RCTs and systematic reviews, which produce the highest level of evidence for intervention research (Polit 30  & Beck, 2017). Each article was critically analyzed and appraised using Joanne Brigg Institute Critical Appraisal Tools, which are considered to be reliable (Polit & Beck, 2017).  4.1.3 Limitations. There is a possibility that some keywords and subject headings were not included, and thus were inadvertently excluded. Also, studies were excluded from the literature review on the following bases: the efficacy of vaginal preparation was not the primary objective (such as care bundles), vaginal preparation in both vaginal and cesarean births were included, were in other languages, and were not available through UBC Summons—and, thus, was inaccessible to the writer. The exclusion of such studies may have reduced the number of studies included in the literature review, affecting the sample size and the power of this project. Therefore, the exclusion of such studies could have limited this SPAR. Furthermore, a meta-analysis was not conducted due to the scope of this project. Meta-analyses are quantitative integrations of findings from similar studies—often RCTs—with the same research question (Polit & Beck, 2017). Meta-analyses offer objectivity and increase power and precision (Polit & Beck, 2017). Meta-analyses also use effect sizes to quantify the magnitude of the relationship between variables (Polit & Beck, 2017). While the existence of a relationship between vaginal preparation and endometritis was established, the magnitude of the relationship was not determined through the literature review. The scale of this study was aligned with the SPAR criteria. While a meta-analysis was beyond the SPAR scope, it would have increased the objectivity, power, and precision of the findings. 4.2 Recommendations This section will outline a clinical practice guideline and evidence-informed recommendations based on the current gaps in the literature synthesized for this project. 31  4.2.1 Clinical practice guideline. The purpose of this clinical practice guideline (CPG) is to identify patients at risk for postpartum endometritis—thus, to promptly and effectively manage risk—and to provide educational materials to patients and point-of-care healthcare providers. 4.2.1.1 Background. About one-third of births in North America occur via cesarean section (CS), also known as cesarean birth or cesarean delivery (Haas et al., 2018; McKibben et al., 2015). However, infectious morbidities, such as endometritis, persist despite technological advances in medicine and administration of prophylactic antibiotics (Göymen et al., 2017; Haas et al., 2018; Zuarez-Easton et al., 2017). Endometritis may lead to delayed recovery, prolonged hospital stay, readmission, and increased healthcare costs, and can negatively impact maternal-infant attachment and bonding as well as the ability of the mother to perform newborn care (Aref, 2019; Zuarez-Easton et al., 2017). Current evidence suggests that vaginal preparation (as referred to as vaginal antisepsis, vaginal cleansing, or vaginal washing) with an antiseptic solution prior to CS may reduce the incidence of endometritis (Ahmed et al., 2017; Aref, 2019; Caissutti et al., 2017; Guzman et al., 2002; Haas et al., 2010, 2018; Memon et al., 2011; Reid et al., 2001; Starr et al., 2005; Yildirim et al., 2012). Trauma- and violence-informed care (TVIC) is a philosophical and practical approach that assumes that everyone has experienced trauma and that violence is ongoing (Browne et al., 2015). Women who have experienced trauma and violence are at increased risk for post-traumatic stress disorder, depression, substance use issues, perinatal loss, placental abruption, antepartum hemorrhage, fear of childbirth, and decreased mother-infant bonding and attachment (Alhusen et al., 2015; Barrios et al., 2015; Kita et al., 2016; Moghaddam Hossieni et al., 2017). However, trauma and violence is a sensitive topic; thus, patients may be hesitant to disclose 32  previous or ongoing trauma and violence. Therefore, HCPs must assume that all patients have experienced trauma and violence and take measures to avoid re-traumatization such as thoroughly explaining procedures to patients and obtaining patient consent prior to all procedures. 4.2.1.2 Operational definition. Postpartum endometritis is defined as a postoperative fever (38.4ºC or greater) that persists past the first 24 hours postpartum, accompanied by purulent vaginal discharge or foul-smelling lochia and uterine tenderness, that requires antibiotic administration. There must be at least two temperature readings of 38.4ºC or greater to rule out an isolated febrile event. 4.2.1.3 Expected outcomes. The implementation of vaginal preparation with povidone-iodine immediately prior to CS is expected to reduce the incidence of postpartum endometritis. 4.2.1.4 Eligibility criteria. Vaginal preparation prior to CS is indicated for women who are at increased risk of developing postpartum endometritis. Risk factors for postpartum endometritis include: prolonged ruptured membranes; prolonged first stage of labour; prolonged second stage of labour; all elective cesarean births; multiple vaginal examinations (i.e., greater than three); presence of an infection such as chorioamnionitis, sexually transmitted infections, urinary tract infection, HIV, or GBS; comorbid conditions that increase risk of infection such as diabetes mellitus (including gestational diabetes mellitus), anemia, long-term steroid administration, or increased maternal weight or BMI; use of a FECG; use of an IUPC; preterm birth, and post-term birth. 4.2.1.5 Exclusion criteria. Contraindications to vaginal preparation prior to cesarean birth include: allergy or hypersensitivity to povidone-iodine, shellfish, or chlorhexidine gluconate; need for emergent CS related to umbilical cord prolapse, abnormal fetal heart rate 33  (such as prolonged deceleration), or placental abruption; placenta previa; vasa previa; known or suspected low-lying placenta; antepartum hemorrhage; face presentation; deeply-impacted fetal presenting part in the maternal pelvis; and need for general anesthesia. 4.2.1.6 Step-by-step procedure. A registered nurse—the circulating nurse or primary nurse—performs vaginal preparation. The implementation of vaginal preparation occurs in the operating room (OR). Adhere to TVIC principles—obtain informed consent before performing vaginal preparation and thoroughly explain the step-by-step procedure to the patient. After the patient has received adequate anesthesia (spinal or epidural anesthesia), perform hand hygiene and gather the supplies required for vaginal preparation: sterile gloves; three sterile sponge sticks (if unavailable, use three sterile gauze balls or three sterile 4 x 4 gauze and one Foerster sponge forceps); sterile dressing tray; sterile pad; and 10% povidone-iodine (use 4% chlorhexidine gluconate if there are contraindications to povidone-iodine). Position the patient for vaginal preparation by flexing the knees and abducting the hips, then place a sterile pad under the patient. Generously pour the 10% povidone-iodine into the sterile dressing tray. Perform hand hygiene and don sterile gloves. Insert Foley catheter and be sure to perform hand hygiene and change sterile gloves prior to vaginal preparation. Saturate the sponge stick in 10% povidone-iodine. Insert the saturated sponge stick two inches into the vaginal cavity. Cleanse the vaginal cavity in a clockwise, circular motion from the vaginal apex to the introitus for 30 seconds. Complete this process three times. Remove the pad from under the patient, and dispose of the materials, as per hospital policy. Remove sterile gloves and perform hand hygiene. Prepare the patient for CS by adducting the hips and bringing the knees together, placing a pillow under the patient’s knees, and securing the legs. Document the patient’s response to the procedure and that procedure was completed.  34  4.2.1.7 Required documentation. A registered nurse and physician records that vaginal preparation was completed on the Interprofessional Progress Notes and the Physician History and Progress Notes, respectively. 4.2.2 Recommendations and implications for clinical practice. This section will discuss recommendations and implications for clinical practice based on the literature. 4.2.2.1 Care bundle. As mentioned previously, care bundles yield outcomes that are better compared to any single intervention (Polit & Beck, 2017). Enhanced recovery after surgery (ERAS) is an example of a surgical care bundle that aims to enhance recovery and minimize the length of hospital stay without forfeiting the quality of care (Corso et al., 2017). The components of ERAS care bundles are classified into three categories: preoperative, intraoperative, and postoperative. Preoperative ERAS components include: prophylactic antibiotic administration prior to incision, preferably a first-generation cephalosporin such as cefazolin; hair removal using clippers; vaginal preparation; and abdominal skin preparation (Duff, 2019; Kawakita et al., 2019; Martin et al., 2018; Money et al., 2018; Shea & Soper, 2019). Intraoperative components include: low transverse abdominal skin incision; removal of the placenta via gentle umbilical cord traction or spontaneous removal of the placenta; closure of the subcutaneous layer if it is greater than 2 cm thick; and closure of the skin using sutures (Duff, 2019; Kawakita et al., 2019; Martin et al., 2018; Shea & Soper, 2019). Finally, postoperative care includes dressing removal 24 hours post-CS (Corso et al., 2017; Kawakita et al., 2019; Shea & Soper, 2019). The combination of these interventions collectively reduces the incidence of postpartum endometritis (Duff, 2019; Kawakita et al., 2019; Martin et al., 2018; Money et al., 2018; Shea & Soper, 2019). Moreover, Corso et al. (2017) suggest scheduled postoperative analgesic 35  administration, early mobilization, early food intake, and early removal of indwelling catheters to further enhance postoperative recovery. 4.2.2.2 Trauma- and violence-informed care (TVIC). As previously discussed, TVIC also assumes that everyone has experienced trauma and that violence is ongoing (Browne et al., 2015). Therefore, it is essential that HCPs take measures to avoid re-traumatization. This is particularly important in the OR, wherein patients temporarily lose the ability to move their lower body (due to anesthesia-related paresis), the lights are bright, and patients must be placed in a position for vaginal preparation—an invasive procedure—that may make them feel vulnerable.  Patients may experience trauma if they feel that HCPs prioritize clinical procedures over the patients’ needs or feelings (Reed et al., 2017). The risk for trauma in childbirth is elevated, especially in those with a history of sexual abuse (Sobel et al., 2018). Therefore, it is of utmost importance to help patients feel safe and heard by respecting patient choice and collaborating with patients when making the decision to perform invasive procedures such as vaginal preparation.  4.2.3 Recommendations and implications for future research. Many of the studies included in this project (Ahmed et al., 2017; Aref, 2019; Asghania et al., 2011; Guzman et al., 2002; Haas et al., 2010; Memon et al., 2011) recommended further research with larger sample sizes to increase power, decrease the risk for a type II error, and increase the likelihood that the sample is representative of the population of interest. Future research should also include more women who were in labour at the time of CS, as this subpopulation was underrepresented in many studies (Ahmed et al., 2017; Aref, 2019; Haas et al., 2010; Starr et al., 2005; Yildirim et 36  al., 2012). A larger sample that is representative of the population of interest, in turn, would maintain the internal and external validities of future research (Polit & Beck, 2017). Moreover, there are currently mixed findings regarding the effect of vaginal preparation on reducing febrile and wound morbidities post-CS (Ahmed et al., 2017; Aref, 2019; Asghania et al., 2011; Guzman et al., 2002; Haas et al., 2010, 2018; Reid et al., 2001; Starr et al., 2005). Thus, further research is needed to evaluate the efficacy of vaginal preparation on post-cesarean febrile and wound morbidities. Furthermore, Caissutti et al. (2017) recommended further research on the impact of vaginal preparation on women with intact membranes and/or who were not in labour at the time of CS. Vaginal preparation has already been included in some surgical care bundles such as ERAS (Duff, 2019; Kawakita et al., 2019; Kawakita & Umans, 2019; Martin et al., 2018; Money et al., 2018). However, the combination of the care bundle components collectively decreases the incidence of infection; therefore, it is difficult to separate the impact of each component. Further research on the separate components—vaginal preparation; abdominal preparation; hair removal; timing, type, and frequency of prophylactic antibiotic therapy; type of incision; removal of the placenta; skin and wound closure; and dressing closure—is required.  4.3 Conclusion Endometritis has significant implications for the mother-infant dyad and the health care system. Vaginal preparation with povidone-iodine immediately prior to CS is a cost-effective and relatively quick—thus, feasible—intervention that can reduce the risk for endometritis (Asghania et al., 2011; Haas et al., 2010; Starr et al., 2005). Following Bayes' theorem for judgment, all possible risks and benefits of vaginal preparation must be considered before performing the procedure (Shaban, 2005). 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International Journal of Women’s Health, 9, 81–88. https://doi.org/10.2147/IJWH.S98876   51  Appendix A: Systematic Search Strategy Database Date Search ID# Search Terms Limits/Filters Yielded Results from Search # Eliminated + Rationale Final Results CINAHL 21-Jan-20 S14 S3 AND S7 AND S12 English language; Academic journals 47 Studies about surgical technique (n=6); studies exclusively about abdominal skin preparation or did not specify vaginal preparation (n=12); studies about antibiotic administration (n=1); studies exclusively about endometriosis (n=3); qualitative studies about women's experiences on recovery, infection (n=1); studies about surgical dressings (n=1); evidence appraisal of a study (n=1); abstracts, poster presentations, practice bulletin, and protocols (n=6); studies about perineal toilet (n=1); editorial commentary (n=1); primary objective not about the efficacy of vaginal preparation (n=8); outcomes did not include infectious morbidity or endometritis (n=1) 5     S13 S3 AND S7 AND S12  54     S12 S8 OR S9 OR S10 OR S11  411,215     S11 infect* OR endometri*  370,085     S10 MH "Endometrial Diseases+"  8,491     S9 MH "Infection+"  160,359     S8 MH "Surgical Wound Infection"  9,782     S7 S4 OR S5 OR S6  4,033     S6 skin N3 (preoperat* OR surg*)  3,804     S5 (MH "Skin Preparation, Surgical")  559     S4 vagina* N3 (prep* OR clean* OR wash* OR antisep*)  247     S3 S1 OR S2  19,954     S2 caesarean* or c-section* or "c section*" or caesarian* or cesarian* or "abdominal deliver*" or "abdominal birth*" or postcaesarean* or post-caesarean* or "post caesarean*" or postcesarean* or post-cesarean* or "post cesarean*" or postcaesarian* or post-caesarian* or "post caesarian*" or postcesarian* or  7,970   52  post-cesarian* or "post cesarian*" or "post c-section*" or "post c section"   S1 (MH "Cesarean Section+")  16,981   MEDLINE 24-Jan-20 1 exp Cesarean Section/  44,347     2 (caesarean* or c-section* or "c section*" or caesarian* or cesarian* or "abdominal deliver*" or "abdominal birth*" or postcaesarean* or post-caesarean* or "post caesarean*" or postcesarean* or post-cesarean* or "post cesarean*" or postcaesarian* or post-caesarian* or "post caesarian*" or postcesarian* or post-cesarian* or "post cesarian*" or "post c-section*" or "post c section").mp. [mp=title, abstract, original title, name of substance word, subject heading word, floating sub-heading word, keyword heading word, organism supplementary concept word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier, synonyms]  24,936     3 1 or 2  56,481     4 (vagina* adj3 (prep* or clean* or wash*)).mp. [mp=title, abstract, original title, name of substance word, subject heading word, floating sub-heading word, keyword heading word, organism supplementary concept word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier, synonyms]  1,190     5 (skin adj3 (preoperat* or surg*)).mp. [mp=title, abstract, original title, name of substance word, subject heading word, floating sub-heading word, keyword heading word, organism supplementary concept word, protocol supplementary concept word, rare disease  4,190   53  supplementary concept word, unique identifier, synonyms]   6 Preoperative Care/  61,056     7 4 or 5 or 6  66,079     8 Surgical Wound Infection/  35,692     9 Infection/  37,878     10 Endometritis/  3,916     11 (infect* or endometri*).mp. [mp=title, abstract, original title, name of substance word, subject heading word, floating sub-heading word, keyword heading word, organism supplementary concept word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier, synonyms]  2,292,512     12 8 or 9 or 10 or 11  2,292,512     13 3 and 7 and 12  114     14 3 and 7 and 12 Journal articles; English language; human subjects 85 Studies exclusively about back skin preparation, abdominal skin preparation or did not specify vaginal preparation (n=6); primary objective not efficacy of vaginal preparation (n=3); duplicates (n=19); studies exclusively about complications of CS (n=3); studies about skin microbiology (n=1); studies exclusively about endometrial/pelvic conditions (n=5); studies exclusive about surgical technique and postoperative care (n=8); studies about prophylactic antibiotics and/or its complications (n=22); article no longer available d/t replaced by updated edition (n=6); studies about miscellaneous procedures (n=5); studies in progress (n=1); studies about cats (n=1) 5 EMBASE 24-Jan-20 1 exp cesarean section/  92,652     2 (caesarean* or c-section* or "c section*" or caesarian* or cesarian* or "abdominal deliver*" or "abdominal birth*" or postcaesarean* or post-caesarean* or "post caesarean*" or postcesarean* or post-cesarean* or "post cesarean*" or  40,515   54  postcaesarian* or post-caesarian* or "post caesarian*" or postcesarian* or post-cesarian* or "post cesarian*" or "post c-section*" or "post c section").mp. [mp=title, abstract, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword, floating subheading word, candidate term word]   3 1 or 2  101,955     4 (vagina* adj3 (prep* or clean* or wash*)).mp. [mp=title, abstract, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword, floating subheading word, candidate term word]  1,614     5 (skin adj3 (preoperat* or surg*)).mp. [mp=title, abstract, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword, floating subheading word, candidate term word]  11,539     6 exp preoperative care/  38,002     7 4 or 5 or 6  50,808     8 exp surgical infection/  43,845     9 exp infection/  3,168,557     10 endometritis/  5,964     11 (infect* or endometri*).mp. [mp=title, abstract, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword, floating subheading word, candidate term word]  2,872,292     12 8 or 9 or 10 or 11  3,956,384     13 3 and 7 and 12  213     14 3 and 7 and 12  86 Studies and articles about prophylactic antibiotics (n=11); duplicates (n=39); studies about surgical technique (n=4);  studies 1 55  exclusively about complications of CS (n=4); studies about miscellaneous procedures (n=16); studies exclusively about endometrial disease (n=2); primary objective not about efficacy of vaginal preparation (n=1); studies exclusively about abdominal preparation or do not specify vaginal preparation (n=1); did not include endometritis (n=6); abstract (n=1) TRIP 24-Jan-20  (title:cesarean or caesarean)(title:infection)  174      (title:cesarean or caesarean)(title:infection)  9 Duplicates (n=4); studies about prophylactic antibiotics (n=1); studies about wound therapy (n=2); studies about infections/infection transmission (n=2) 0    (title:cesarean or caesarean)(title:infection)  12 Studies about wound therapy (n=1); duplicates (n=2); commentary (n=1); studies about surgical techniques/equipment (n=5); studies about prophylactic antibiotics (n=2); studies about other procedures (n=1) 0    (title:cesarean or caesarean)(title:infection)  115 Studies about infections/infection transmission (n=9); duplicates (n=24); studies about complications of CS (n=26); studies about wound therapy (n=5); studies about surgical techniques/equipment (n=1); studies about diagnostics (n=1); studies about mHealth (n=1); studies about prophylactic antibiotics (n=28); case study/report (n=3); primary objective not about efficacy of vaginal preparation (n=2); no longer available d/t replaced with an updated edition (n=3); abstract/poster presentation (n=1); studies about other procedures (n=3); studies about surgical technique (n=5); commentary (n=2); unavailable through UBC Summons (n=1) 0 Ancestry approach 25-Jan-20  Haas et al. (2018) Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections (Review)  2 additional Abstract (n=1); included vaginal delivery (n=1) 0    Caisutti et al. (2017) Vaginal cleansing before cesarean delivery: A systematic review a meta-analysis  7 additional Included vaginal delivery (n=1); included vaginal antibiotic (n=1); unavailable through UBC Summons (n=5) 0   56  Descendancy approach 01-Feb-20  Aref (2017) Vaginal cleansing prior to caesarian section: To do or not to do?   1 additional Unavailable through UBC Summons (n=1) 0     57  Appendix B: Matrix for Key Research Components Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments Author(s): Reid, V.C., Hartmann, K.E., McHahon, M., & Fry, E.P.  Year: 2001 To determine effect of pre-CS vaginal preparation with povidone iodine on post-cesarean infectious morbidity Study design: - RCT - Informed consent was obtained - Randomization was achieved using a computer-generated system - Used sequentially numbered opaque envelopes - Physicians who reviewed the patient charts were blinded.  Sample: - Power calculation was done to determine minimum sample size to detect a 10% difference in absolute risk and to accommodate - 501 women who had cesarean births were enrolled between May 1996 and September 1998 - 3 women were excluded from data analysis due to missing charts  Inclusion criteria:  - All women admitted to L&D Type of antiseptic solution: 10% povidone-iodine  Length of vaginal preparation: Not specified  Number of swabs used for vaginal preparation: 3  Method: - Iodine-soaked 4 x 4-in gauze - Performed by resident physicians after adequate anesthesia and Foley catheter insertion - “fold and grasp one or two of the saturated gauze sponges at a time with a sterile sponge stick, and to prepare the field from the vaginal apex to the introitus with attention to anterior, posterior, and lateral aspects Yes / No / Unclear  If yes, type of antibiotics (if specified): N/A Endometritis: Postop fever accompanied with uterine or abdominal pain/tenderness requiring broad-spectrum IV antibiotics—Note: the antibiotics were to be prescribed for the treatment of uterine or pelvic infection only  Fever: Temp ≥ 38ºC after the day of surgery  Febrile morbidity: Postop fever persisting past the 1st 24 hours, lasting at least two days  Clinical endometritis: Temp elevation after the 1st postop day in addition to uterine or abdominal pain or tenderness, which required broad-spectrum IV antibiotics Data collection:  - Two physicians reviewed charts at least 3 months after discharge - MFM and OB/GYN independently assigned diagnostic outcome codes after reviewing chart - Discrepancies were resolved through discussion with a 3rd OB/GYN  Data analysis: - Intention-to-treat analysis - Used Stata Statistical Software - t test used for continuous data - RR and 95% CI based on Pearson’s χ2 test used to analyze association between dichotomous outcomes and vaginal preparation - “The Mantel-Haenszel test of - There is a possible increase in risk of endometritis in women in the intervention group were not in labour prior to CS - There was no statistically significant difference in wound complications - "Vaginal preparation with povidone iodine before cesarean had no effect on the incidence of fever, endometritis, or wound infection" (p. 147) Strengths:  - Operational definitions were established a priori - Those who were reviewing charts were blinded to assignment - Power calculation was performed to determine sample size - There were very little discrepancies in data analyses   Limitations: - Non-English speaking women were also included, but measures taken to ensure accurate translation was not outlined à unsure if consent was truly informed  - Inconsistent use of prophylactic antibiotics could have affected results - Inconsistent method used for vaginal - Further study is needed - Vaginal preparation may be beneficial, but further studies should investigate a different antiseptic solution or method/ timing of vaginal preparation - Study site seems over >2,800 births per year - Ethics approval not explicitly stated 58  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments - Able to consent to CS  Exclusion criteria: - Medical contraindications such as allergy to povidone-iodine, iodine, or shellfish; highly emergent CS; active genital herpes; bleeding placenta previa  Study setting: University of North Carolina Women's Hospital, USA of the vaginal walls" (p. 148)  Control: No vaginal preparation (fever not required)   Wound separation: Surgical site separation requiring intervention such as operative debridement or dressing changes homogeneity was used to evaluate potential heterogeneity in stratified analyses of ratio measures" (p. 149) preparation could have affected results, as residents were allowed to use one or two gauzes—thus, amount of solution used could have been affected - Use of definitions endometritis and clinical endometritis could have been confusing—some overlap could have occurred - Wound infection was outlined as one of the outcomes, but was not included in the results Author(s): Guzman, M. A., Prien, S.D., & Blann, D.W.   Year: 2002 To determine the effect of pre-CS vaginal preparation on rate of postop infection Study design: - RCT - Ethics approval obtained from the institutional review board - Informed consent obtained - Random allocation to intervention or control groups - Surgeons and physicians responsible for the postpartum care of Type of antiseptic solution: Betadine (povidone-iodine)  Length of vaginal preparation: 3 minutes  Method: The scrub nurse placed the betadine-soaked Yes / No / Unclear  If yes, type of antibiotics (if specified): N/A Endometritis: At least two readings of a temp >100.4ºF (38ºC) after the 1st 24 hours postop OR temp >101ºF (38.3ºC) at any time after CS accompanied by uterine or abdominal tenderness  Data collection: - After discharge from the hospital, participants were followed up until their clinic visit - Data on readmissions to ERs, patient demographics and infection rates were collected - There were no statistically significant differences in patient demographics  - There was a statistically significant reduction in endometritis in the treatment group (p<0.04) Strengths: - Those caring for patients were blinded - Power analysis was performed to determine sample size - Randomized allocation of participants into treatment and control groups  Limitations: Details of Further study with a larger sample size is needed to confirm results of the current study Study site is a tertiary centre that sees >2,000 births per year 59  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments the participants were blinded.  Sample: - Power analysis done to determine minimum sample size to detect a statistically significant - 160 women were enrolled from March 2000 to July 2001  Inclusion criteria: - All women undergoing cesarean delivery  Exclusion criteria: - Medical contraindications such as allergy, placenta previa, need for emergent CS  Study setting: University Medical Center, Lubbock, Texas, USA  sponge stick (gauze) at the apex of the vagina and held it in the vaginal vault  Number of swabs used for vaginal preparation: 1  Control: Normal saline (same procedure) Cellulitis: "advancing erythema around the incision" (p. 207)  Data analysis: - SPSS version 8.0 was used to analyze all data - Student t test, ANOVA, and χ2 were used - There was no statistically significant reduction in cellulitis in the treatment group (p=0.12) - Vaginal preparation with povidone-iodine prior to CS can reduce rates of endometritis but not cellulitis, even in pts with increased VEs, regardless of increased BMI, DM, and membrane status sample recruitment, randomization process, and data collection and analysis were not outlined Author(s): Starr, R. V., Zurawski, J., & Ismail, M.  Year: 2005 To determine the effect of pre-CS vaginal preparation with povidone-iodine on risk for Study design: - RCT - Approval was obtained by the Institutional Review Board of the University of Chicago Hospitals Type of antiseptic solution: Povidone-iodine  Length of vaginal preparation: Yes / No / Unclear  If yes, type of antibiotics (if specified): Either clindamycin or cefazolin Febrile morbidity:  Postop temp > 38ºC  Endometritis: Elevation in temp > 38.4ºC that persists Data collection:  - After discharge from the hospital, patient charts were reviewed (after six weeks - There were no significant differences in patient demographics or maternal comorbid conditions Strengths:  - Those analyzing results were blinded - Randomized allocation - Power calculation was Further studies are needed to confirm the findings of this study before implementa-tion Internally funded (funded by the University of Chicago Hospitals Resident 60  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments endometritis and wound infection - Informed consent was obtained - Random allocation was done using a random digit table - Allocation was concealed using sealed, opaque, sequentially numbered envelopes - The physician who reviewed the charts was blinded  Sample:  - Power calculation (α= 0.05, 80% power) was performed to determine the minimum sample - 400 women were recruited from November 1997 to March 2000 - 92 were excluded from analysis due to the following reasons: patient information (identification) lost, violations of inclusion criteria, charts unavailable  Inclusion criteria: - All women undergoing nonemergent CS  30 seconds (each swab)  Method: - Used prepackaged foam sponge sticks saturated with povidone-iodine - Done at the time of abdominal preparation - “Each sponge stick was rotated 360º in the vagina” (p. 1025)  Number of swabs used for vaginal preparation: 2  Control: Standard abdominal preparation with povidone-iodine (at the time of umbilical cord clamping beyond the first 24 hours postop, associated with foul-smelling lochia and uterine tenderness (must rule out other sources of infection through physical or laboratory evidence)  Wound infection:  Wound edge separation or erythema around surgical site accompanied by purulent drainage postpartum) by one physician - Diagnoses were not assigned by chart reviewer - Collected data on diagnoses, maternal comorbid conditions, and patient demographics  Data analysis: - The SAS System was used to analyze data - Fisher exact test or continuity-adjusted χ2 was used to compare proportions (due to number of patients) - “Logistic regression was used for the multivariate modeling of the data” (p. 1025) - Intention-to-treat analysis was used - There was a statistically significant reduction in rates of endometritis in the treatment group - Risk for developing endometritis was significantly increased in history of antenatal UTI, severe anemia, or use of internal monitors - Vaginal preparation decreases the risk of endometritis but not necessarily the overall risk of febrile morbidity performed to determine sample size  Limitations:  - There was a significant amount of data lost due to unavailable data, unavailability of hospital charts, and exclusion for violation of recruitment criteria  - Relatively small sample size due to attrition—there is a risk that results were overestimated - Some subgroups were not included in analysis, such as those who exhibited s/s of endometritis but were afebrile—results could have been affected Research Fund) 61  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments Exclusion criteria: - Vaginal delivery - Diagnosis of chorioamnionitis, placenta previa  Study setting: Chicago Lying-In Hospital, Chicago, Illinois, USA Author(s): Haas, D.M., Pazouki, F., Smith, R.R., Fry, A.M., Podzielinski, I., Al-Darei, S.M., & Golichowski, A.M.   Year: 2010 To determine the effect of pre-CS vaginal preparation with povidone-iodine on risk of postop maternal morbidities Study design: - RCT - Informed consent was obtained - Randomized allocation using a computer-generated random number table - Allocation concealment using sealed, opaque sequentially-numbered envelopes - Surgeons and participants were not blinded, but were also not explicitly told which group to which the participant was allocated  Sample: - A power calculation was done to determine sample size (α= 0.05, 80% power) - 300 women were recruited from Type of antiseptic solution: Povidone-iodine 1%  Length of vaginal preparation: Unspecified  Method: - Performed after Foley catheter insertion and before abdominal preparation - Used prepackaged sterile sponge sticks saturated in povidone-iodine - Changed gloves before abdominal preparation - “The vaginal scrub encompassed the vaginal apex to the introitus Yes / No / Unclear  If yes, type of antibiotics (if specified): A cephalospor-in Endometritis: Postop fever that requires antibiotic accompanied with uterine tenderness  Wound complication: Infection of the surgical site that requires antibiotics; hematoma; seroma; wound separation; or need for debridement Data collection: - Data on reason for CS, surgical characteristics, duration of labour, and maternal and infant characteristics and demographics were collected - A research assistant who was blinded to the allocation group collected the data at the time of discharge from the hospital and at one month PP - “The Regenstrief Institute's computerized medical record system and a hand search of postpartum records were performed for demographic - There was no statistically significant difference in baseline demographics data - Vaginal preparation with povidone-iodine was associated with reduced incidence of postop infectious morbidities, though not statistically significant Strengths: - Those assessing outcomes were blinded - Definitions of outcomes were established a priori - Power calculation was performed to determine sample size  Limitations: - Small sample size and stopping the trial prematurely may increase risk for type II errors—falsely conclude that there is no difference when there is - Large number of sample were not in labour since it was easier to obtain consent from “Adequately powered trials are needed to adequately demonstrate this benefit in a statistically significant manner for the most clinically relevant outcomes”(p. 310.e5) - Internally funded - Consent forms available in English and Spanish - Trial is registered at ClinicalTrials.gov (#NCT00386477) - Ethics approval not explicitly stated 62  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments September 2006 to January 2009  Inclusion criteria: - All women over 18 years of age undergoing CS - Capable of giving informed consent  Exclusion criteria: - Planned cesarean hysterectomy - Allergy to iodine-containing solutions  Study setting: Three hospitals affiliated with the Department of Obstetrics and Gynecology at Indiana University School of Medicine—University Hospital (tertiary care referral centre); Wishard Memorial Hospital (urban county hospital); Methodist Hospital (large urban hospital), Indiana, USA  with attention to the anterior, posterior, and lateral walls including all fornices." (p. 310.e2)  Number of swabs used for vaginal preparation: 3  Control: Standard abdominal scrub characteristics and presence of postoperative fever, endometritis, and early wound complications." (p. 310.e2)   Data analysis:  - All data were entered into a Microsoft Access database, which was deidentified - All data were analyzed using SPSS version 16.0 - Used an intent-to-treat analysis - Used χ2 test to assess the association between dichotomous outcomes and vaginal preparation - Used continuity corrections to calculate RR and 95% Cis - Used Student’s t test to compare continuous variables  women who were not in labour—sample may not have been representative of population 63  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments Author(s): Asghania, M., Mirblouk, F., Shakiba, M., & Faraji, R.  Year: 2011 To assess the effect of pre-CS vaginal preparation with povidone-iodine on post-CS infectious morbidity  Study design: - Clinical trial - Ethics approval obtained by the Guilan University of Medical Sciences ethical review committee - Informed consent was obtained - Participants were assigned alternately to treatment and control groups - Participants were not told which group to which they were assigned - The physician who reviewed the charts was blinded  Sample: - Power calculation was done to determine sample size - 585 women were enrolled from May 2007 to April 2008 - 10 subjects from the treatment group and 7 from the control group were not included in analysis due to attrition  Inclusion criteria: Type of antiseptic solution: Povidone-iodine 10%  Length of vaginal preparation: 30 seconds (each swab)  Method:  - Used 4 x 4 cm gauze saturated in povidone-iodine solution - Performed before abdominal preparation - Rotated gauzes 360º “from the upper part of the vagina to the outlet" (p. 401)  Number of swabs used for vaginal preparation: 2  Control: Standard abdominal preparation Yes / No / Unclear  If yes, type of antibiotics (if specified): "one dose of cephazolin i.v., 30 min before the operation and three doses postoperatively" (p. 401) Endometritis: Elevation in temp >38.4ºC that persists beyond the 1st 24 hours postop, accompanied by uterine tenderness and foul-smelling lochia (must rule out other sources of infection)  Wound infection:  Wound edge separation or erythema around the surgical site accompanied with purulent drainage  Febrile morbidity: Postop temp >38ºC past the 1st 24 hours postop “Other sources of infection that contributed to a high fever, such as urinary tract infection, pneumonia, atelectasis, breast engorgement or drug sensitivity were not Data collection: - Data on demographics, medical history, obstetric history, duration of ROM, presence of meconium, duration of labour, duration of CS, and number of VEs were collected - During hospitalization, uterine tenderness, lochia, incision, and temperature were assessed QID for 48-72 hours - Diagnosis was given at time of clinical evaluation, and re-evaluated at the end of the 1st week, 3rd week, and 6th week postop  - There were no statistically significant differences in baseline characteristic between the two groups for some characteristics but not all - There was a decreased risk for fever, but not statistically significant - There is “a slight but significant decrease in post-caesarean endometritis after vaginal preparation with povidone-iodine” (p. 401) Strengths: - Double-blinded - “bias was minimal as all data were reviewed by one physician, without the knowledge of patient assignment to either arm of the study” (p. 401) - Power calculation was performed to determine sample size - Used logistic regression model to control for the effect of confounding variables   Limitations: - High risk for selection bias due to lack of randomization and lack of allocation concealment Further studies with adequate randomization and a larger sample size is needed - Trial was registered at IRCT.IR 64  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments - All women undergoing nonemergent CS - All women who were laboring  Exclusion criteria: - Emergent CS due to bleeding placenta previa or fetal distress - Abnormal vaginal discharge in pregnancy - Gestational herpes - Hypersensitivity to povidone-iodine - Active chorioamnionitis  Study setting: Al-Zahra Maternity Hospital, Iran  considered as fever” (p. 401)  Author(s): Memon, S., Qazi, R.A., Bibi, S., & Parveen, N.  Year: 2011 To assess the effect of pre-CS vaginal preparation with an antiseptic solution on post-CS infectious morbidity Study design: - Observational case control study - Informed consent was obtained - Women were randomly assigned to the intervention or control group  Sample: - 200 participants were enrolled from February 2010 to July 2010  Type of antiseptic solution: Povidone-iodine 10%  Length of vaginal preparation: Unspecified  Method: - Performed after adequate anesthesia and insertion of Foley catheter Yes / No / Unclear  If yes, type of antibiotics (if specified): Third generation cephalosporin (during the surgery) Postoperative febrile morbidity: Oral temp ≥ 38ºC that persists after the 1st 24 hours postop  Endometritis:  Postop fever ≥ 38.4ºC that requires broad-spectrum IV antibiotics, accompanied with foul-smelling lochia Data collection: - Data were collected from hospital charts - Data on risk factors for infection (such as DM, anemia) were collected   Data analysis:  - All data were entered and analyzed in SPSS version 15 - There were no significant differences in patient demographics, surgical variables, labour, and maternal comorbid conditions - Vaginal preparation is associated with a statistically significant decrease in Strengths: - Operational definitions were established a priori - “Measurement bias was minimal because the physicians who evaluated the data were unaware of any patient’s participation in the study” (p. 1180)  - Recommend implementing vaginal preparation - Before implementing vaginal preparation, further adequately powered studies are required to confirm the findings of this study  - Ethics approval was not explicitly stated - Was it meant to be a case-control study or an RCT? - If an RCT, what was the randomization process? Were participants 65  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments Inclusion criteria: - All women undergoing CS over 18 years of age - Able to give informed consent  Exclusion criteria: - Bleeding placenta previa - Allergy to iodine-containing solutions  Study setting: Department of Obstetrics and Gynaecology Unit-III, Liaquat University Hospital Hyderabad, Pakistan - Used sterile gauzes saturated in povidone-iodine to clean “from the vaginal apex to the introitus with attention to the anterior, posterior and lateral vaginal wall” (p. 1180)  Number of swabs used for vaginal preparation: 3  Control: Standard abdominal scrub and uterine tenderness  Wound complication:  Surgical site infection that requires IV antibiotics and wound care—includes hematoma, seroma, and wound separation  composite infectious morbidities, especially in those who were in active labour (and even more so for those with ROM) Limitations: - Study is labelled an observational case-study, yet participants were randomly assigned to treatment and control groups—there was an intervention - Did not list limitations and assessors blinded? Author(s): Yildirim, G., Güngördük, K., Asicioğlu, O., Basaran, T., Temizkan, O., Davas, I., & Gulkilik, A.  Year: 2012 To assess the effect of vaginal preparation with povidone-iodine on incidence of post-CS endometritis Study design: - RCT - Ethics approval was obtained from the hospitals' ethics committee - Informed consent was obtained - Randomized allocation using a computer-generated randomization process - Used sealed envelopes containing random numbers–Type of antiseptic solution: Povidone-iodine  Length of vaginal preparation: 30 sec  Method: - Performed at the same time as abdominal preparation - Used prepackaged foam sponges Yes / No / Unclear  If yes, type of antibiotics (if specified): One dose of either cefazolin or clindamycin (at the time of CS) Fever: Elevation in temp ≥ 38ºC at least 24 hours following CS, “not associated with lower abdominal or pelvic tenderness, or other signs of infection” (p. 2317)  Wound infection: "partial or total separation of the incision, as Data collection: - Demographic information was collected for all participants - “Signs of wound infection (erythema, swelling, discharge, or tenderness), vaginal discharge, uterine consistency and height, and peritonitis were assessed daily - There were significant differences in endometritis between the two groups, but when those with ROM were excluded from the analysis, there was no significant difference - There was no significant difference in fever or Strengths: - Power calculation was performed to determine sample size - Large sample size  Limitations: - Researchers were not blinded à possible bias when assessing outcomes - The authors identified that one limitation None listed - Registered with the federal government (NCT01437228) - Declared no conflict of interest 66  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments participants were allocated to a group according to the number   Sample:  - Power calculation was done to determine sample size (α = 0.05, 80% power) - An addition 10 subjects were recruited to account for attrition - 670 women were enrolled from January 2011 to August 2011  Inclusion criteria: - All women undergoing CS (elective or emergency) - Gestational age ≥ 38 weeks  Exclusion criteria:  - Allergy to povidone-iodine - Medical contraindications (placenta previa, umbilical cord prolapse)  Study setting: Bakirkoy Women's and Children's Teaching Hospital containing povidone-iodine - “Both sponges were inserted into the vagina and rotated 360º in the vaginal cavity” (p. 2317)  Number of swabs used for vaginal preparation: 2  Control: Standard abdominal preparation well as the presence of purulent or serous wound discharge with induration, warmth and tenderness" (p. 2317)  Endometritis: "body temperature greater than 38.5ºC with concomitant foul-smelling discharge or abnormally tender uterus on bimanual examination" (p. 2317) in all participants” (p. 2317) - CBC (24h PP) and urinalysis was done on all participants - “Participants returned to the Bakirkoy Women’s and Children’s Teaching Hospital at 2 and 6 weeks post-delivery to assess complications and signs of infection” (p. 2317)  Data analysis: - Used χ2 to analyze categorical variables - Used Student’s t test and Mann-Whitney U-test to analyze continuous variables - Calculated RR and 95% CI - Statistical significance was set at p<0.05  wound infection - There were significant differences in endometritis rate in women who were in labour at the time of CS, but when excluded, there was no significant difference - Vaginal preparation with povidone-iodine is beneficial for women with ruptured membranes or who were in labour at the time of CS  was more than half of the participants were not in labour at the time of CS, and that VEs were not performed on those who were not in labour and whose membranes were intact à results may have been affected 67  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments + Sisli Etfal Training and Research Hospital, Istanbul, Turkey Author(s): Ahmed, M.R., Aref, N.K., Sayed Ahmed, W.A., & Arain, F.R.  Year: 2017 To determine the effect of vaginal preparation with chlorhexidine on rates of post-CS infectious morbidity Study design: - RCT - Ethics approval obtained from the Suez Canal University ethics committee - Informed consent was obtained - Participants were randomly allocated into the treatment and control groups using 218 sealed envelopes, half of which had notes labeled study group and the other half labeled control group - Women were asked to select an envelope “to determine the group to which she would be allocated” (p. 1485)   Sample: - Power calculation was done to determine a sample size (α = 0.05, 80% power) - 218 women were enrolled from Type of antiseptic solution: Chlorhexidine acetate 0.25%  Length of vaginal preparation: 1 minute  Method: - Performed by the scrub nurse after adequate spinal anesthesia and Foley catheter insertion - Used 10 x 10 cm sterile gauze saturated with chlorhexidine to wash “the vaginal apex including fornices in clockwise manner to the introitus with attention to the anterior, posterior and lateral vaginal walls” (p. 1485)  Number of swabs used for vaginal preparation: 3 Yes / No / Unclear  If yes, type of antibiotics (if specified): cefotaxime 1 g IV (immediately prior to skin incision) Endometritis: Postop fever ≥ 38.4ºC at least twice 24 hours post-CS, accompanied by persistent foul-smelling lochia and uterine tenderness  Febrile morbidity: Temp ≥ 38ºC persisting after the 1st 24 hours postop in the absence of s/s of other infections (UTI, chest infection, breast engorgement)  Wound infection: Wound separation or erythema around the surgical site accompanied by purulent drainage that requires wound care and antibiotics Data collection: - Maternal infectious morbidities were assessed “at the time of hospital discharge and weekly [until] the end of [the] postpartum period” (p. 1485)  Data analysis: - Data were analyzed using SPSS version 15 - Used mean ± SD to express quantitative data - Used numbers and percentages to express qualitative data - Used Student t test significance of difference of quantitative variables - Used χ2 to test significance of qualitative variables - Two-sided statistical significance - There was no statistically significant difference in baseline characteristics between the two groups for some characteristics (age, parity, gestational age, BMI, operative time, postop hospital stay) - There was no significant difference in fever and wound infection between the two groups - Vaginal preparation with chlorhexidine was associated with a statistically significant reduction in post-CS infectious morbidity (particularly endometritis) Strengths: - Double-blinded - Used randomization - Power calculation was performed to determine sample size  Limitations: - Risk for attrition bias and overestimation of results - Only elective CS were included, thus not representative of entire population - Lack of results on the effect of vaginal preparation on neonatal outcomes  - Relatively small sample size  - Recommend a longitudinal study to address the effect of vaginal preparation on neonatal outcomes - A study with a larger sample size is required to confirm the results of this study - Did not specify whether or not envelopes were opaque - Declared no conflict of interest or financial support 68  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments October 2014 to December 2015 - During the follow-up period, 7 participants from the treatment group and 11 participants from the control group were lost  Inclusion criteria: - Women undergoing elective CS - Term, singleton pregnancy  Exclusion criteria: - Emergency CS due to placenta previa or premature ROM - Women who are immunocompromised (long-term steroid therapy, DM)  Study setting: Suez Canal University Hospitals, Egypt  Control: Standard abdominal preparation was set at p < 0.05 Author(s): Caissutti, C., Saccone, G., Zullo, F., Quist-Nelson, J., Felder, L., Ciardulli, A., & Berghella, V. To determine the effect of vaginal preparation on post-CS endometritis Study design: - Systematic review  - "The review protocol was designed a priori to define methods for collecting, extracting, and analyzing data. Type of antiseptic solution:  - Povidone-iodine (n=11)—10% (n=4), 5% (n=1), 1% (n=2), did not report % (n=4) Yes / No / Unclear  If yes, type of antibiotics (if specified):  - All studies used intraoperative surgical or "The primary outcome was the incidence of endometritis as defined by the original trials. Secondary outcomes were postoperative wound Data collection:  - Risk of bias was assessed in terms of: 1) allocation concealment, 2) random sequence generation, 3) - Overall risk of bias was low - There was no statistically significant difference in incidence of endometritis Strengths: - Appropriately combined studies—studies that could not be combined were analyzed separately - Analyzed subgroup - Recommend vaginal preparation prior to CS for at least 30 seconds - Further studies are needed to determine Registered with the PROSPERO Int’l Prospective Register of Systematic Reviews (CRD42017054843) 69  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments  Year: 2017 The research was conducted with the use of MEDLINE, Ovid, EMBASE, Scopus, Clinicaltrials.gov, and Cochrane Library as electronic databases by two independent reviewers...The trials were identified with the use of a combination of the following text words: "vaginal irrigation," "cesarean," "pregnancy," "infection," "caesarean," "endometritis," "povidone-iodine," "chlorhexidine," "trial," and "randomized"...Review of articles also included the abstracts of all references that were retrieved from the search. No restrictions for language or geographic location were applied" (p. 528)  Sample: - 16 RCTs "from the inception of - Chlorhexidine diacetate (n=3) —0.2% (n=2), 0.4% (n=1) - Metronidazole 0.5% 5 g vaginal gel (n=1) - Cetrimide 50 cc (n=1)  Length of vaginal preparation: - 30 sec (n=4) - 60 sec (n=1) - 3 min (n=1)  Method: - Used vaginal gel (n=1) - Used vaginal scrubs (n=1) - Used sterile gauze (n=1) - Used syringe (n=1) - Did not specify (n=1)  Control:  - Placebo (n=5) - No treatment (n=10) prophylactic antibiotics - Timing included: before incision (n=6), after cord clamping (n=6), either after cord clamping or before incision (n=2), didn’t report timing (n=2); also postop (n=3) infection; postoperative fever greater than 38ºC or 100.4ºF and other wound complications including postoperative wound seroma or hematoma" (p. 529) incomplete data, 4) blinding of outcome assessment, 5) blinding of participants and personnel, 6) selective reporting, and 7) other bias. - Risk of bias were labeled: low risk, high risk, and unclear risk - Collected “data regarding vaginal cleansing procedure and incidence of infective complications” (p. 529) as well as duration and type of solution used - Data were extracted without modification  Data analysis:  - Data analysis was completed by two reviewers (independently) using Review Manager 5.3 - Discrepancies were resolved through discussion with a third reviewer comparing vaginal cleansing with povidone-iodine and with chlorhexidine - There was a statistically significant reduction in endometritis, particularly for those who were in labour and whose membranes were ruptured  analyses to determine effect on different subgroups  Limitations: - “Some published trials comparing vaginal cleansing with either placebo or no treatment were excluded because they included both vaginal and cesarean delivery without stratifying data for mode of delivery. Inclusion of data of cesarean delivery only from these RCTs could modify our findings” (p. 536) - “there was high variability of study implementation such as timing of antibiotics, placental removal technique, diagnosis of endometritis, and socioeconomic status of enrolled whether vaginal preparation for women whose membranes are intact and for those who are not in labour 70  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments each database to January 2017" (p. 528)  Inclusion criteria:  - RCTs comparing vaginal preparation with a control (placebo or no vaginal preparation) using any method with any type of antiseptic solution performed ≤ 1 hour prior to CS  Exclusion criteria: - RCTs about vaginal delivery or that did not include outcomes of interest - "studies in which prophylactic surgical antibiotics were explicitly not used" (p. 529)  Study setting: - In addition to studies already included—USA (n=3), Thailand (n=1); Egypt (n=2); Bangladesh (n=1); Iran (n=1) - Used mean±SD for continuous outcomes - Used random-effects model of DerSimonian and Laird to perform meta-analysis “to produce summary treatment effects in terms of mean difference or [RR] with 95% CI” (pp. 532-533) - Used Higgins I2 to assess heterogeneity - Begg’s and Egger’s tests were used to assess potential publication biases women. These variables could have affected out findings” (p. 536) - Included a study with vaginal preparation with an antibiotic—may have been a confounder Author(s): Haas, D.M., Morgan, S., Contreras, To determine the effect of vaginal preparation with Study design: - Systematic review - Authors searched the Type of antiseptic solution: - Povidone-iodine (n=8) Yes / No / Unclear  If yes, type of antibiotics (if PRIMARY OUTCOMES: Post-cesarean endometritis: Data collection: - All potential studies were assessed - Vaginal preparation with povidone-iodine or Strengths: - Subgroup analyses were performed - More information is required "on whether other methods of - Declared no conflict of interest - Internally funded by 71  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments K., & Enders, S.  Year: 2018 antiseptic solution before CS on maternal morbidities Cochrane Prgnancy and Childbirth's Trials Register, which included trials from CENTRAL, MEDLINE, EMBASE, CINAHL, as well as ClinicalTrials.gov, and the WHO ICTRP for unpublished, planned, and ongoing trials - Hand-searched journals and conference proceedings, used email alerts for journals, and searched reference list (from retrieved studies) - Two people screened the search results - Medical subject headings and keywords included: Administration, Intravaginal; Anti-Infective Agents, Local; Benzalkonium Compounds; Cesarean Section; Chlorhexidine; Disinfection; Endometritis; Fever; Povidone-Iodine; Preoperative Care; - Chlorhexidine (n=2) - Benzalkonium chloride (n=1)  Length of vaginal preparation:  - Not specified in analysis  Method: - Not specified in analysis  Number of swabs used for vaginal preparation: - Not specified in analysis  Control: - No vaginal preparation (n=8) - Vaginal preparation with normal saline (n=3) specified): Not specified in analysis (Clinical diagnosis) Fever, purulent lochia, or uterine/fundal tenderness that requires antibiotic therapy  SECONDARY OUTCOMES: Postoperative fever: > 38ºC or 100.4ºF  Postoperative wound infection: Tenderness, erythema, purulent draining from surgical site that requires antibiotic therapy (may or may not have fever)  Postoperative wound seroma or hematoma: "collection of serous fluid or blood/clot in the subcutaneous area of the incision" (p. 7)  Composite wound complications:  independently by at least three authors - Data from eligible studies were reviewed by at least two authors  - Discrepancies were resolved through discussion - All data were entered into Review Manager - Tried to contact authors of original studies if data was unclear - Risk for bias was assessed independently by three authors using the Cochrane Handbook for Systematic Reviews of Intervention - Biases were assessed as being at low, high, or unclear risk and included: selection bias (random sequence generation; allocation concealment), performance bias (blinding chlorhexidine prior to CS reduces incidence of endometritis - Subgroup analyses suggest reduced incidence in endometritis, particularly in women who were in labour or whose membranes had ruptured— “subgroup analyses should be interpreted with caution, however, as the number of participants and events is relatively low” (p. 18) - The overall risk of bias "is reasonably low to moderate, with only a few areas being identified as potential sources of high risk of bias" (p. 18), particularly blinding of - Multiple authors independently collected and analyzed data, thereby reducing risk for bias - Authors of Haas et al. study did not assess the study, therefore reducing risk for bias - Low risk of bias in review process d/t data collection and analyses were completed independently by four authors with minimal discrepancies that required resolution through consensus  Limitations: - Variability in study implementation and “reporting of the data outcomes and the subgroup data stratification” (p. 18) could have impacted results vaginal preparation reduce postoperative infectious morbidity" (p. 18) - Consistency in adverse event reporting and the definitions of postoperative infectious morbidity is required to data synthesis - Further research on “the impact of bundles of care surrounding reducing post-cesarean endometritis and other infectious morbidity can help determine the impact of multiple interventions in this area. In addition, factor analyses can help discover the most important components of preoperative Indiana University School of Medicine 72  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments Randomized Controlled Trials; Surgical Wound Infection; Vagina; female; humans; pregnancy  Sample: - 11 RCTs that assessed any method of vaginal preparation with any type of antiseptic solution performed ≤ 1 hr prior to CS on women undergoing CS (elective, urgent, or labouring)  Inclusion criteria: - Randomized trials, quasi-randomized trials, and cluster-randomized trials that assessed the effect of vaginal preparation with an antiseptic solution prior to CS versus placebo or standard of care on post-CS infectious morbidity  Exclusion criteria: - Trials that did not use prophylactic antibiotics or "that The presence of any of the following: seroma, wound separation, hematoma, wound infection  Other secondary outcomes included: adverse effects of vaginal preparation and composite wound complications or endometritis of participants and personnel), detection bias (blinding of outcome assessment), attrition bias (incomplete outcome data), reporting bias (selective reporting), and other bias - The GRADE approach was used to assess the quality of the evidence  Data analysis: - Used RR with 95% CIs to present dichotomous data - Continuous data were presented as “mean difference (MD) if outcomes were measured in the same way between trials…[and] standardized mean difference (SMD) to combine trials that measured the same outcome, but used different methods” (p. 9) participants and providers bundles” (p. 18) 73  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments utilized vaginal preparation during labor" (p. 1)  Study setting: - In addition to studies already included—Pakistan (n=1); Turkey (n=1) -  Intention-to-treat analysis was used - Tau2, I2, and χ2 were used to assess statistical heterogeneity - Fixed-effect meta-analysis was used to combine data "where it was reasonable to assume that studies were estimating the same underlying treatment effect" (p. 10) - Random-effects meta-analysis was used "if there was clinical heterogeneity sufficient to expect that the underlying treatment effect differed between trials, or if substantial statistical heterogeneity was detected" (p. 10)  Author(s): Aref, N.K.  Year: 2019 To determine the effect of pre-CS vaginal preparation with povidone-Study design: - RCT - Informed consent was obtained - Participants were randomly Type of antiseptic solution: Povidone-iodine 10%  Yes / No / Unclear  If yes, type of antibiotics (if specified): cefotaxime 1 Endometritis: Postop fever ≥ 38.4ºC at least twice 24 hours post-CS, accompanied by persistent foul-Data collection:  - Participants were assessed daily until discharge from hospital + - There were no statistically significant differences in baseline characteristics Strengths: - Assessors were blinded to assignment - Randomization  Further studies with larger studies are required to confirm findings of this study Ethics approval was not explicitly stated 74  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments iodine on infectious morbidities allocated into the treatment and control groups using two sealed envelopes, one of which had notes labeled study group and the other labeled control group - Women were asked to select an envelope “to determine the group to which she would be allocated” (p. 66)   Sample: - Power calculation was done to determine a sample size (α = 0.05, 80% power) - 226 women were enrolled from September 2016 to December 2017 - During the follow-up period, 7 participants from the treatment group and 12 participants from the control group were lost  Inclusion criteria: - Women undergoing elective CS - Term, singleton pregnancy  Length of vaginal preparation: 1 minute  Method: - Performed by the scrub nurse after the insertion of a Foley catheter  - Used two sterile gauzes saturated with povidone-iodine to wash “the vaginal apex including fornices in clockwise manner to the introitus” (p. 66)  Number of swabs used for vaginal preparation: 2  Control: Standard abdominal preparation g IV (immediately prior to skin incision) smelling lochia and uterine tenderness  Febrile morbidity: Temp ≥ 38ºC persisting after the 1st 24 hours postop in the absence of s/s of other infections (UTI, chest infection, breast engorgement)  Wound infection: Wound separation or erythema around the surgical site accompanied by purulent drainage that requires wound care and antibiotics weekly until the end of postpartum period for s/s of wound infection, foul-smelling vaginal discharge, and uterine height and consistency  Data analysis:  - All data were analyzed using SPSS release 22 for Microsoft Windows - Mean and SD, percentages, and frequencies were used to analyze data - χ2 test (cross tabulation) was used to compare groups - Statistically significance was set at p < 0.05 between the two groups - There was a statistically significant difference in the incidence of post-CS infectious morbidity and endometritis - There were no significant differences in fever and wound infection Limitations: - Listed febrile morbidity as an outcome, but there was no operational definition - Relatively small sample size 75  Author(s), year  Objective Method Intervention and control Use of prophylactic antibiotics Outcomes and definitions of outcomes Data collection and analysis Results Strengths and limitations Recommen-dations Comments Exclusion criteria: - Emergency CS - Autoimmune disease or immunocompromised (long-term steroid therapy, DM) - PROM - Positive BV and/or GBS culture within two weeks prior to CS  Study setting: King Abdul-Aziz Hospital, Saudi Arabia  Notes: No adverse effects of vaginal preparation were noted, but also not explicitly assessed in any of the studies76  This page intentionally left blank. 

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