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Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study.. Norman, Wendy V; Kaczorowski, Janusz; Soon, Judith A; Brant, Rollin; Bryan, Stirling; Trouton, Konia J; Dicus, Lyda Jun 14, 2011

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TRIALSImmediate vs. delayed insertion of intrauterinecontraception after second trimester abortion:study protocol for a randomized controlled trialNorman et al.Norman et al. Trials 2011, 12:149http://www.trialsjournal.com/content/12/1/149 (14 June 2011)STUDY PROTOCOL Open AccessImmediate vs. delayed insertion of intrauterinecontraception after second trimester abortion:study protocol for a randomized controlled trialWendy V Norman1,2*, Janusz Kaczorowski1,2,4, Judith A Soon1,3,4, Rollin Brant1,5, Stirling Bryan1,4,6,Konia J Trouton1,2,7 and Lyda Dicus1,8AbstractBackground: We describe the rationale and protocol for a randomized controlled trial (RCT) to assess whetherintrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies thancurrent recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests thenovel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlightsconsiderations of design, implementation and evaluation of a trial expected to provide rigorous evidence forappropriate insertion timing and health economics of intrauterine contraception after second trimester abortion.Methods/Design: Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention) orfour weeks (recommended care) post abortion. Primary outcome measure is pregnancy rate at one year. Secondaryoutcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economicanalyses comparing immediate and delayed insertion groups, and device retention rates, complication rates(infection, expulsion) and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires,clinical records and British Columbia linked health databases will be used to assess primary and secondaryoutcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and isexpected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014.Discussion: The RCT design combined with access to clinical records at all provincial abortion clinics, and toinformation in provincial single-payer linked administrative health databases, birth registry and hospital records,offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one through fiveyears among enrolled women. We highlight considerations of design, implementation and evaluation of a trialexpected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterinecontraception after second trimester abortion.Trial registration: Current Controlled Trials ISRCTN19506752IntroductionAbortion is common in Canada with 96,815 reported in2005 [1]. Canadian women seeking abortion represent ahigh risk group for recurrent unintended pregnancy as 38%have had at least one previous abortion [2]. About 12% ofall abortions occur past the 12th week in pregnancy(second trimester)[3,4]. Women seeking abortion in thesecond trimester are disproportionately from marginalizedand vulnerable populations [3-6], and recurrent unintendedpregnancies may further exacerbate social and economicdisadvantages [7]. The most effective contraceptive is “for-gettable”[8], that is: a method requiring user attention nomore often than every 3 years. Intrauterine contraception(IUC) is efficacious, and thus highly effective contraception[9-12]. Robust evidence exists to favour immediate* Correspondence: wvnorman@interchange.ubc.ca1Contraception & Abortion Research Team, Women’s Health ResearchInstitute, Vancouver, British Columbia, V6H 1G3, CanadaFull list of author information is available at the end of the articleNorman et al. Trials 2011, 12:149http://www.trialsjournal.com/content/12/1/149 TRIALS© 2011 Norman et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative CommonsAttribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction inany medium, provided the original work is properly cited.insertion of an IUC after first trimester abortion [13-19]and post-partum [20-23].To minimize expulsion and potential for perforation ofthe IUC device, current recommended care and productmonographs indicate delaying insertion after a secondtrimester abortion until substantial uterine involution(return to non-pregnant size): typically 4-6 weeks [24,25].This recommendation appears to be founded upon a the-oretical risk of greater rates for expulsion prior to uterineinvolution, as we were unable to find published evidenceto support this assertion. Although the rates for bothexpulsion and perforation are believed to be only margin-ally higher than for insertion at 4 weeks [26,27], as few as26% of women return by 6 weeks for a planned delayedinsertion [28].British Columbia (BC) administrative health databasestrack health care services provided within a single-payeruniversal health care system. These databases enable alinkage of study participant information to health systemdata on all births, abortions, miscarriages, any pregnancyrelated visits, hospital admissions and prescriptions dis-pensed following study enrollment. This method cansubstantially reduce attrition rate in a population knownto have low post abortion follow up adherence [27-31].The proposed randomized controlled trial (RCT) ofimmediate compared to a planned delayed device inser-tion following second trimester abortion is the first toexamine both the levonorgestrel and the copper deviceand the first to report on pregnancy rate at one year asthe primary outcome measure. The study will providegeneralizable results using an intention-to-treat frame-work for the hypothesis: Intrauterine contraceptionplaced immediately after a second trimester abortion willresult in fewer pregnancies than current recommendedcare of intended placement at 4 weeks post-abortion. Thehealth economic analysis of costs and cost-effectivenesswill facilitate determination of population health implica-tions to inform health systems and health care deliverydecisions.MethodsStudy designWomen having a second trimester abortion at any BCabortion clinic, and choosing an IUC for post-abortioncontraception will be eligible to participate in the study.Consenting participants choose either a copper or alevonorgestrel-releasing IUC and are then randomlyallocated to an insertion time immediately or four weeksafter their abortion. Contraception Satisfaction Ques-tionnaires (CSQ), clinical records and the linked provin-cial health administrative databases will be accessed todetermine all pregnancies occurring within one year ofenrollment, supplemented with a variety of secondaryoutcomes.Sample Size and Power Calculations350 women choosing a levonorgestrel-releasing IUC(LNG-IUC, “Mirena®”, Bayer Inc, Canada), and 366women choosing a “T” shaped copper IUC with 380mm2 surface area of copper including copper bands onthe “T” arms (CuT380-IUC, “Flexi-T380(+)®”, Prosan,The Netherlands) will be recruited and randomly allo-cated to each of two treatment arms: immediate inser-tion (experimental intervention) vs. planned delayedinsertion (recommended care), representing a totalenrollment of 716 women into this Phase IIIb RCT (SeeTable 1). This sample size will provide 90% power inthe levonorgestrel stratum to distinguish predicted oneyear pregnancy rates of 1.2% (immediate) versus 8.7%(delayed) and 80% power for corresponding detection of2.7% and 9.7% in the copper device users.Estimation of Probable Rates of PregnancyThe pregnancy rates used in our sample size calculationare justified as follows. The one year failure rate of theLNG-IUC device is known to be 0.1%[32] except in thecase of spontaneous expulsion that we conservativelyestimate occurs when immediately inserted after secondtrimester abortion with a probability of 0.05 (observedrate 0.03 by Drey [27] and Cremer [29]). Our estimatedpost-abortion pregnancy probability in the absence of anIUC is 0.24 [33]. Therefore the estimated pregnancy ratein the immediate insertion LNG-IUC group is expectedto be:A = .95× . 01 + .05× .24 = .013In the delayed group, we conservatively estimate 65%of women will return for insertion of the IUC (Stanekfound 26% return for planned delayed insertion [28],and Cremer 30%[29]), and we assume (conservatively)the high expulsion rate of the immediate insertiongroup. These assumptions imply a one-year pregnancyrate ofB = .65× A + .35× .24 = .092The one year failure rate for the CuT380-IUC is 1.7%[34]. Using the above formula this yields rates forimmediate and delayed insertion of .028 and .102respectively. Allowing for a loss to follow-up of up to5% provides conservative estimates of the observedTable 1 Enrollment AllocationImmediate Delayed TotalLNG-IUC 175 175 350CuT380-IUC 183 183 366Total 358 358 716Norman et al. Trials 2011, 12:149http://www.trialsjournal.com/content/12/1/149Page 2 of 8pregnancy rates of .012 and .0874 in the LNG-IUCcohort and .027 and .097 in the CuT380-IUC group.Inclusion CriteriaAll women at participating study sites who have com-pleted informed consent for an abortion over 12 andunder 24 weeks gestational age (as determined by ultra-sound), who are residents of BC enrolled in the univer-sal provincial medical services plan and have chosen touse an IUC for post-abortion contraception are eligibleto participate.Exclusion CriteriaWomen are not eligible if they intend to move from BCwithin the next year or if they intend to conceive withinone year. In addition, if they have a contraindication tothe use of the IUC they have chosen (see Table 2) orare currently enrolled in another clinical trial they willbe excluded. Post randomization exclusion factorsinclude perforation or excessive bleeding at the time oftheir abortion or uterine anomaly detected at the timeof the abortion procedure. These exclusions aredesigned to be only those which, in real life, would pre-clude a woman from being able to choose this methodof contraception. This study has no minimum age cri-teria for enrollment.Participating Study ClinicsAll five surgical abortion clinics offering second trime-ster abortion in the province of BC are collaborating inthis study. The geographic catchment areas for theclinics include both urban and rural areas, and servicethrough these clinics is provided in both hospital andfree-standing publicly-funded outpatient settings.Enrollment processAll women presenting to a participating clinic for anabortion of a pregnancy over 12 weeks and under 24completed weeks receive information on the researchstudy web page [35] at the time they book their appoint-ment, and a study information brochure upon check in.Women consenting to participate complete an initialCSQ. Participants receive their chosen IUC at no cost inaddition to a gift card and are randomly allocated usingTable 2 Inclusion and Exclusion CriteriaInclusion Criteria - This study will be offered to women at the study sites who meet all of the following criteria:Have completed informed consent for an abortion over 12 and under 24 weeks gestational age.Have chosen an IUC (either LNG-IUC or CuT380-IUC) for contraception post abortion.Are residents of British Columbia registered with the Medical Services Plan health care system.Exclusion CriteriaIntention to move from BC within the next yearIntention to conceive within the next yearUterine cavity anomalies causing distortion of the endometrial canal including fibroids of more than 5 cm, excluding repaired uterine septumCurrent untreated PID, Chlamydia, gonorrhea, cervicitis or lower genital tract infection (recent infection is not a contraindication to IUC insertion[35])Wilson’s Disease (if choosing a CuT380-IUC)Undiagnosed abnormal uterine bleedingKnown uterine or cervical malignancy or cervical dysplasiaKnown or suspected progestin-dependent neoplasia, including breast cancer (if choosing a LNG-IUC)Active liver disease or dysfunction (if choosing a LNG-IUC)Actual benign or malignant liver tumours (if choosing a LNG-IUC)Hypersensitivity to levonorgestrel or any of the other ingredients in the formulation or component of the container components of Mirena® (ifchoosing a LNG-IUC)Bacterial endocarditisEstablished immunodeficiency (HIV positivity is not an exclusion unless immunodeficient)Acute malignancies affecting blood or leukemiasRecent trophoblastic disease while hCG levels are elevatedCurrently enrolled in another investigational studyPost Randomization Exclusion CriteriaFailure to undergo an abortion (ie: participants who elect to continue their index pregnancy at any time subsequent to randomization)Uterine perforation at the time of abortionBleeding of more than 500 cc during abortionUterine cavity anomalies as outlined aboveNorman et al. Trials 2011, 12:149http://www.trialsjournal.com/content/12/1/149Page 3 of 8an internet-based randomization service [36], toimmediate or planned delayed insertion, with stratifica-tion for device, parity and clinic site. This trial has beenregistered at controlled-trials.com (ISRCTN19506752).A pilot phase study undertook to develop, pilot test andfocus group review the CSQ from an existing validatedquestionnaire [37], adapted for use in our populationand for this study, including translation into the threemost common non-English languages in our population(Cantonese, Mandarin and Punjabi). A user-friendlyinternet based format for each of the four languages andsampling times (intake, three, six and 12 month andannually to five years) was implemented.Immediate insertion group protocolWomen randomized to immediate insertion have theirchosen IUC inserted by their surgeon immediately follow-ing the abortion prior to leaving the procedure or operat-ing room. As per standard clinic protocols all women inboth groups have polymerase chain reaction (PCR) testingfor chlamydia and gonorrhoea prior to their abortion, andreceive two grams metronidazole single observed dose asprophylaxis against postoperative infection [38]. Womendeemed to be at higher risk of a sexually transmitted infec-tion (as per criteria used by all BC clinics [38]), and thosewith positive PCR results, receive one gram of azithromy-cin as well. An ultrasound image of the IUC in situ isrecorded. If an ultrasound machine is not immediatelyavailable in the operating room, arrangements are madefor an ultrasound to be performed to confirm proper IUCposition.Delayed insertion group protocolWomen randomized to planned delayed insertion aremanaged as closely as possible to standard practice. Parti-cipants are asked to make an appointment for follow-upand IUC insertion at 4 +/-1 weeks after the date of theirabortion. All women are offered one month of an alter-nate contraceptive. An opportunity to return for follow-up and IUC insertion at any study clinic is available to allwomen, as per recommended post abortion delayed IUCinsertion practice. Participants who have travelled over100 km from a study clinic are asked to make arrange-ments for insertion in their home community. Studyparticipants experience conditions as close to standardnon-study delayed insertion conditions as possible. Thesewomen receive a “SmartPayment”® card [39] and a pre-scription for the IUC. This permits participants to receivethe IUC cost-free (as is the case for those able to returnto the study clinic for insertion) and for the patient’spharmacy of choice to be reimbursed for the IUC. Theparticipant is also given a requisition for a post-insertionultrasound. The BC Medical Services Plan provides pay-ment for the IUC insertion and the post-insertionultrasound. This procedure is designed to as closely aspossible emulate the real-life conditions each participantwould experience were she not in a research study. Thisprocess eliminates possible bias in IUC insertion rate,and thus pregnancy rate, were she to take home a freestudy IUC or we to courier it to her designated healthcare provider.Outcome determinationCSQ are offered by mail, email or as a web-based ques-tionnaire at 3, 6 and 12 months and annually to five yearsfollowing enrollment. The CSQ collect data on expulsionof IUC, effectiveness and satisfaction with contraceptivemethod and insertion timing assigned, any removal ofthe IUC, any change to contraceptive method or inten-tion to conceive, any interval pregnancies and their out-comes, and any adverse events. In addition participantsare asked to arrange to return to any of the study sites orsee their primary health care provider for a follow-upclinical examination at 3, 6 and 12 months following theabortion. Information from clinical visits and CSQ willbe used in conjunction with BC administrative healthdatabase information to determine outcomes.Ethical AspectsThis study has received institutional review boardapproval from the following research ethics boards: theUniversity of British Columbia-Children’s and Women’sResearch Ethics Board (H10-00306), the Interior HealthAuthority Research Ethics Board (2010-028) and theVancouver Island Health Authority Clinical ResearchEthics Board (C2010-47). A Data and Safety MonitoringBoard has been established consisting of an Obstetrician-Gynaecologist, a biostatistician, an expert in Populationand Public Health and database linkage research, and aneconomist specializing in population health pharmaceuti-cal economics, all from Canadian universities outside ofBC, and each being independent of all members of theresearch team. Funding for this study is primarilythrough grants from the Canadian Institutes for HealthResearch, with pilot funding and administrative supportfrom the Women’s Health Research Institute, and theUniversity of British Columbia. Donation of 385 freeMirena devices was provided by Bayer Inc. as their solecontribution to the research study.AnalysisPrimary outcome will be examined in an intention-to-treat framework as pregnancy rate at one year amongwomen randomized to immediate insertion compared towomen randomized to a planned insertion at 4 weeks("delayed insertion”) for each of the two IUC devices.For example, if women in the delayed group present forinsertion after the specified 4+/-1 week insertionNorman et al. Trials 2011, 12:149http://www.trialsjournal.com/content/12/1/149Page 4 of 8window, or even at the time of a subsequent abortion ordelivery, we will insert the device at the women’srequest and her assignment for the primary analysis willnot change. Similarly if for any reason a womanassigned to the immediate insertion group is unable tohave her insertion immediately (for example, should shehave an unattended expulsion/delivery of her pregnancyprior to the planned surgical abortion) then insertionwill be offered at the time the woman and her physicianwould normally undertake to do so, and whether or nother insertion ever occurs, her assignment for the pur-pose of analysis will not change. Thus our primary out-come of pregnancy rate at one year reflects real lifeconditions.Secondary outcomes include: costs and cost effective-ness, cumulative annual pregnancy rate, device insertionrate, loss to follow-up; continuation of method; adverseevents (such as infection or perforation); expulsion; out-comes among those participants who were chlamydiapositive at the time of insertion; satisfaction with IUCchosen and with insertion timing assigned. These out-comes will be assessed initially at one year, then annuallythrough the five year device effectiveness period.Operational definition for outcomeAlthough our outcome of one year pregnancy rate is con-ceptually simple, exact determination of conception datesis clearly infeasible. Consequently our actual outcomedefinition provides a pragmatic approximation based onthe varying exactitude of imputations based on provincialMedical Service Plan billings related to abortions, miscar-riages, still births and live births. Subsequent abortionsperformed within our study clinics for enrolled partici-pants will be noted along with specific clinical informa-tion on pregnancy duration. For abortions performedelsewhere such as those for BC university students study-ing out of province, or those performed by individualphysicians at rural or remote hospitals within BC, exactgestation may not be available. In the BC health adminis-trative databases abortions are billed as under 7 weeksfor medical abortions, and as under 14 weeks, 14 weeksto under 18 weeks, and 18 weeks and over for surgicalabortions. Miscarriages by definition occur anytimeunder 20 weeks or are classed as still birth when over 20weeks of gestation. Thus for subsequent pregnancieswhere the specific gestation is unknown, we will considera pregnancy to have occurred in the first year accordingto the following conservative adjustments to one year fol-low-up dates. (see Table 3.)Analysis methodsWe will compare one year pregnancy rates using a chi-squared test declaring significance if p < .05 and provide95% confidence intervals for the difference in pregnancyrates using the large sample normal approximation fordifferences in proportions. This simple approach is validso long as no systematic difference in follow-up occursbetween groups. As a check, we will also conduct analysisto account for partial follow-up. Since our outcome defi-nition is essentially composite and the relevant risk peri-ods differ by components, Kaplan-Meier estimates foreach component event will be determined and compositeestimates will be obtained by summing the estimatedcumulative event rates (calculated as 1 - the survivalfunction) at the time-points indicated in our operationaldefinitions. Confidence intervals around the difference inthese estimates will be calculated using the bootstrap.Rates for all secondary outcomes will be calculated forevents occurring within one year following abortion, andannually for five years, using the follow-up question-naires, direct access to clinical follow up visit records,and billing and procedure coding data from the admin-istrative health system databases. Multivariate logisticregression will be used to examine demographic, socioe-conomic, and obstetrical factors in relationship to pri-mary and secondary objectives.Survey AnalysisThe quantitative data from the CSQ will be analyzed usingdescriptive statistics. The CSQ contain several scales pro-viding composite scores that can be used to indicate differ-ences in the secondary outcomes. Open ended questionswill be analyzed through content analysis focusing on keytopics.Health Economic AnalysisEconomic analysis seeks to provide comparative informa-tion on the costs and benefits of alternative clinical strate-gies. In this study the strategy of interest is the immediateIUC insertion after second trimester abortion versus thedelayed insertion. The economic analysis will provide esti-mates of the improvements in benefits associated withsuch a potential health policy change, and the associatedcosts.Given the nature of the clinical condition, it would beinappropriate for benefits to be measured using quality-adjusted life years (QALYs). Therefore a cost-effective-ness analysis will be conducted whereby the measure ofeffect is simply the number of unintended pregnanciesprevented. The primary focus for the economic analysiswill therefore be estimating resource use and costs, withthe main measure of benefit not valued explicitly withinthe analysis but a presumption that avoiding unintendedpregnancies is inherently a positive outcome.A broad perspective will be adopted to include costsincurred within the health care sector (such as contra-ception, abortion, medications etc.), those incurred byother sectors (e.g. social services for fostering andNorman et al. Trials 2011, 12:149http://www.trialsjournal.com/content/12/1/149Page 5 of 8adoption) and those incurred by women and theirfamilies. In line with the main trial, the time span forcollection of resource and cost data will be one year inthe first instance and then data collection will beextended to five years. The process of collectingresource use data will be undertaken separately fromdata collection on unit costs. Data on use of resourcesin the health and welfare sectors will be gathered fromthe linked health and administrative databases of thegovernment of British Columbia and managed by Popu-lation Data BC. Similarly, data on use of resources inother sectors is also available from routine sources, withlinking of data to be performed for this work. Unit costswill be obtained and attached to resource items in orderthat a cost can be calculated for each trial participant.Unit costs will be obtained from published sources andcentres participating in the trial.A within-trial economic analysis will be carried out,adopting an incremental approach in that data collectionwill concentrate on resource use and outcome differencesbetween trial arms. As the majority of cost data areskewed, and the mean cost of each procedure is ofimportance, non-parametric bootstrapping will be usedto estimate confidence intervals around the mean costsand benefits. To reflect the differential timing of costsbeing incurred and benefits being experienced, discount-ing will be applied according to standard guidelines.The results will be presented as incremental cost-effectiveness ratios (ICERs) and cost-effectivenessacceptability curves (CEACs). The robustness of theresults will be explored using sensitivity analysis, toinvestigate uncertainties in the data, the analysis meth-ods and the generalizability of the results to othersettings.DiscussionAnticipated LimitationsChanges in intention-to-conceiveDue to our exclusion criteria, we recruit only womenwho do not intend to conceive within the first year afterenrollment. Nevertheless, in this study population withan anticipated mean age of 24, we fully anticipate someindividuals will change their intent to conceive over thefirst and subsequent study years. We will account forthis in two ways. First we ask at each CSQ (three, sixand 12 months and annually to 5 years) about the intentto conceive, and second, we assume randomization willdistribute those who have intended pregnancies withinthe study period evenly to both arms of the study.ExpulsionsMost women are aware of an IUC expulsion [40], andshould it occur, will make arrangements for alternatecontraception. This alternate contraception may be areplacement device or a change of contraceptive method.Each participant will be provided with a toll free numberenabling them to contact the Principal Investigator(WVN) at any time. In addition, the study team willmonitor follow up visits, CSQ, Medical Services Plan bill-ings and prescription records of alternate contraceptionprescribed or an IUC inserted. In this manner, we believewe will be able to estimate device expulsion rate with afair degree of accuracy. In order to most accuratelyreflect usual contraceptive conditions in the event of anexpulsion, we are not providing a free replacementdevice. We have stratified at randomization for parity, asthis may be a factor in expulsion.SummaryThis paper highlights considerations of design, imple-mentation and evaluation of a randomized controlledtrial expected to provide rigorous evidence for appropri-ate insertion timing and health economic considerationsfor the two most common forms of intrauterine contra-ception after second trimester abortion.AbbreviationsBC: British Columbia, a province in Canada; CEACs: Cost-EffectivenessAcceptability Curves; CSQ: Contraception Satisfaction Questionnaires;CuT380-IUC: Copper Intrauterine Contraception ("Flexi-T380(+)®®” Prosan, TheNetherlands); ICERs: Incremental Cost-Effectiveness Ratios; IUC: IntrauterineContraception; LNG-IUC: Levonorgestrel-releasing IUC ("Mirena®®”, Bayer Inc,Canada); PCR: Polymerase Chain Reaction; QALYs: Quality-Adjusted Life Years;RCT Randomized Controlled TrialTable 3 Operational definition of a pregnancy as derived from administrative billing dataBilling Type Nominal weeks of gestation Cut-off for operational definitionAbortion (medical) < 7 weeks* 1 year + 4 weeksAbortion (surgical) < 14 weeks 1 year + 6 weeksAbortion (surgical) 14-18 weeks 1 year + 13 weeksAbortion (surgical) ≥ 18 weeks 1 year + 17 weeksMiscarriage < 20 weeks 1 year + 11 weeksStill birth ≥ 20 weeks 1 year + 25 weeksLive birth Birth date - GA 1 year + XX**In Canada, mifepristone is not available. Medication-induced abortions using methotrexate and misoprostol are offered in British Columbia up to a maximum of49 days (7 weeks) from last menstrual period.** Where XX = median conceptual age for live births in BC.Norman et al. Trials 2011, 12:149http://www.trialsjournal.com/content/12/1/149Page 6 of 8Acknowledgements and FundingThis study is funded through an Operating Grant and a Primary Health CareBridge Funding Grant, both from the Canadian Institutes of Health Research.The levonorgestrel releasing IUC used in this study were donated by BayerInc., Canada as their sole contribution to the study. Neither organization wasinvolved in any manner with the study design, or with the collection,analysis, and interpretation of data; or in the writing of the manuscript; or inthe decision to submit the manuscript for publication.Author details1Contraception & Abortion Research Team, Women’s Health ResearchInstitute, Vancouver, British Columbia, V6H 1G3, Canada. 2Department ofFamily Practice, University of British Columbia, Vancouver, British Columbia,V6T 1Z3, Canada. 3Faculty of Pharmaceutical Sciences, University of BritishColumbia, Vancouver, British Columbia, V6T 1Z3, Canada. 4School ofPopulation and Public Health, University of British Columbia, Vancouver,British Columbia, V6T 1Z3, Canada. 5Department of Statistics, University ofBritish Columbia, Vancouver, British Columbia, V6H 3V4, Canada. 6The Centrefor Clinical Epidemiology & Evaluation, Vancouver Coastal Health ResearchInstitute, Vancouver, British Columbia, V5Z 1M9, Canada. 7Vancouver IslandWomen’s Clinic, Victoria, British Columbia, V9B 1T2, Canada. 8CARE Program,British Columbia Women’s Hospital and Health Centre, Vancouver, BritishColumbia, V6H 3N1, Canada.Authors’ contributionsWN, JK, JS, RB, SB, LD made substantial contributions to conception anddesign of this study. 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Crenin MD: Conception rates after abortion with methotrexate andmisoprostol. Int J Gynaecol Obstet 1999, 65(2):183-8.Norman et al. Trials 2011, 12:149http://www.trialsjournal.com/content/12/1/149Page 7 of 834. United Nations Development Programme, United Nations Population Fund,World Health Organization and World Bank, Special Programme ofResearch, Development and Research Training in Human Reproduction:Long-term reversible contraception: Twelve years of experience with theTCu380A and TCu220C. Contraception 1997, 56(6):341-52.35. Norman WV: Better Contraceptive Choices Research. Contraception &Abortion Research Team, UBC 2011 [http://www.bcc4me.ca].36. Randomize.net: Ottawa: Biometrix Helath Research Services, Inc.; 2011[http://www.randomize.net/index.html].37. Colwell HH, Mathias SD, Cimms TA, Rothman M, Friedman AJ, Patrick DL:The ORTHO BC-SAT - a satisfaction questionnaire for women usinghormonal contraceptives. Quality of Life Research 2006, 15:1621-1631.38. Montgomery CA, Norman WV, Money DM, Rekart ML: Antibioticprophylaxis at the time of induced abortion. BC Medical Journal 2002,44(7):367-73.39. Smart Technology: Nova Scotia: Sampling Technologies Inc.; 2008 [http://www.smartsti.com/index.php/solutions/by_solution/tim_test].40. Neuteboom K, de Kroon CD, dersjant-Roorda M, Jansen FW: Follow-upvisits after IUD insertion: Sense or nonsense? A technology assessmentstudy to analyze effectiveness of follow-up visits after IUD insertion.Contraception 2003, 68(2):101-4.doi:10.1186/1745-6215-12-149Cite this article as: Norman et al.: Immediate vs. delayed insertion ofintrauterine contraception after second trimester abortion: studyprotocol for a randomized controlled trial. Trials 2011 12:149.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submitNorman et al. Trials 2011, 12:149http://www.trialsjournal.com/content/12/1/149Page 8 of 8

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