Comparing the effectiveness of copper intrauterine devices available in Canada. Is FlexiT non-inferior to NovaT when inserted immediately after first-trimester abortion? Study protocol for a randomized controlled trial

Trials

Janusz Kaczorowski⁴  Andra Aslan²  Rollin Brant³  Caroline A Turner²  Jessica L Chiles²  Wendy V Norman¹ 

[1] School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, V6T 1Z3, Canada;Department of Family Practice, University of British Columbia, Vancouver, British Columbia, V6T 1Z3, Canada;Department of Statistics, University of British Columbia, Vancouver, British Columbia, V6H 3V4, Canada;Département de médecine familiale et médecine d’urgence, L’Université de Montréal, Montréal, Quebec, Canada

关键词: Canada;    Randomized controlled trial;    Non-inferiority trial;    Therapeutic abortion;    Abortion-induced;    Contraception effectiveness;    Intrauterine device expulsion;    Intrauterine device;    Contraception;   

Others  :  1095382
DOI  :  10.1186/1745-6215-13-147

 received in 2012-07-16, accepted in 2012-08-09,  发布年份 2012

【 摘 要 】

Background

We describe the rationale and protocol for a randomized noninferiority controlled trial (RCT) to determine if the Flexi-T380(+) copper intrauterine contraceptive device (IUD) is comparable in terms of effectiveness and expulsion rates to the most common Canadian IUD currently in use, NovaT-200, when placed immediately after a first-trimester abortion.

Methods/Design

Consenting women choosing to use an IUD after an abortion for a pregnancy of less than 12 weeks of gestation will be randomized to device-type groups to receive immediate post-abortion placement of either a Flexi-T380(+) IUD, a device for which no current evidence on expulsion or effectiveness rates is available, or the Nova-T200 IUD, the only other brand of copper IUD available in Canada at the time of study initiation. The primary outcome measure is IUD expulsion rate at 1 year. Secondary outcomes include: pregnancy rate, method continuation rate, complication rates (infection, perforation), and satisfaction with contraceptive method. A non-intervention group of consenting women choosing a range of other post-abortion contraception methods, including no contraception, will be included for comparison of secondary outcomes. Web-based contraception satisfaction questionnaires, clinical records, and government-linked health administrative databases will be used to assess primary and secondary outcomes.

Discussion

The RCT design, combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry, and hospital records, offers a unique opportunity to determine if a novel IUD has a comparable expulsion rate to that of the current standard IUD in Canada, in addition to the first opportunity to determine pregnancy rate and method satisfaction at 1 year post-abortion for women choosing a range of post-abortion contraceptive options. We highlight considerations of design, implementation, and evaluation of the first trial to provide rigorous evidence for the effectiveness of current Canadian IUDs when inserted after first-trimester abortion.

Trial registration

ClinicalTrials.gov Identifier NCT01174225

【 授权许可】

   
2012 Norman et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Norman WV: Induced abortion in Canada 1974-2005: Trends over the first generation with legal access. Contraception 2012, 85(2):185-189. http://www.contraceptionjournal.org/article/S0010-7824(11)00424-0/fulltext webcite
• [2]Statistics Canada: Induced Abortions 2005. The Daily Wed May 21,2008. [Internet]. 2011. Available from: http://www.statcan.gc.ca/daily-quotidien/080521/dq080521c-eng.htm. webcite
• [3]Canadian Institutes for Health Information: Induced abortions performed in Canada in 2009. Canadian Institutes of Health Information, Institutes of Health; 2012 Aug 6. Canadian Institutes of Health Information [Internet] accessed: 2012 Aug 6 available at: http://www.cihi.ca/CHI-ext-portal/pdf/internet/TA_09_ALLDATATABLES20111028_EN webcite
• [4]Fisher WA, Singh SS, Shuper PA, et al.: Characteristics of women undergoing repeat induced abortion. CMAJ. 2005, 172:637-641.
• [5]Prager SA, Steinauer JE, Foster DG, Darney PD, Drey EA: Risk factors for repeat elective abortion. Am J Obstet Gynecol 2007, 197:575. e1-575.e6
• [6]Ames CM, Norman WV: Preventing repeat abortion: is the immediate insertion of intrauterine devices post-abortion a cost effective intervention associated with fewer repeat abortions in a Canadian population? Contraception 2012, 85(1):51-55. http://www.contraceptionjournal.org/article/S0010-7824(11)00206-X/fulltext webcite
• [7]Prosan: Flexi-T Product Monograph: T300, T300(+). T380(+). Prosan International BV. Arnhem. Health Canada Licence: 64100, The Netherlands; 2007.
• [8]Stanwood NL, Grimes DA, Schulz KF: Insertion of an intrauterine contraceptive device after induced or spontaneous abortion: A review of the evidence. BJOG 2001, 108(11):1168-1173.
• [9]Bednarek PH, Creinin MD, Reeves MF, Cwiak C, Espey E, Jensen JT, Post-Aspiration IUD, Randomization (PAIR) Study Trial Group: Immediate versus delayed IUD insertion after uterine aspiration. N Engl J Med 2011, 364(23):2208-2217.
• [10]Thonneau PF, Almont TE: Contraceptive efficacy of intrauterine devices. AJOG 2008 Mar, 198(3):248-253.
• [11]Blumenthal PD, Voedisch A, Gemzell-Danielsson K: Strategies to prevent unintended pregnancy: increasing use of long-acting reversible contraception. Hum Reprod Update 2011, 17(1):121-137.
• [12]ESHRE Capri Workshop: Intrauterine devices and intrauterine systems. Hum Reprod Update 2008, 14(3):197-208.
• [13]Goodman S, Hendlish SK, Reeves MF, Foster-Rosales A: Impact of immediate post abortal insertion of intrauterine contraception on repeat abortion. Contraception 2008, 78(2):143-148.
• [14]Grimes DA, Lopez LM, Schulz KF, Stanwood N: Immediate postabortal insertion of intrauterine devices. Cochrane Database Syst Rev 2007, 4:CD001777.
• [15]Medical Rounds Discussion: Post-Abortion Contraception. Department of Family Practice, Kelowna General Hospital, Kelowna, British Columbia, Canada; 2009.
• [16]O’Brien PA, et al.: Copper-containing, framed intrauterine devices for contraception: a systematic review of randomized controlled trials. Contraception 2008, 77:318-327.
• [17]United Nations Development Program: Long-term reversible contraception: Twelve years of experience with the TCu380A and TCu220C. Contraception 1997, 56:341-352.
• [18]Baeyertz JD, Hartfield VJ: The Nova-T 200 intrauterine contraceptive device: a 12 year study. N Z Med J 1997 May 9, 110(1043):169-171.
• [19]World Health Organization Task Force on Intrauterine Devices for Fertility Regulation: IUD Insertion following Termination of Pregnancy: A Clinical Trial of the TCu220C, Lippes Loop D, and Copper 7. Stud Fam Plann 1983, 14(4):99-108.
• [20]Neuteboom K, de Kroon CD, Dersjant-Roorda M, Jansen FW: Follow-up visits after IUD-insertion: Sense or nonsense? A technology assessment study to analyse effectiveness of follow-up visits after IUD insertion. Contraception 2003, 68(2):101-4.
• [21]Blackwelder WC: “Proving the null hypothesis” in clinical trials. Control Clin Trials 1982, 3:345-353. Pubmed ID 7160191
• [22]Patten S: Sample Size for an Equivalence Study: Sample Size Calculator. University of Calgary. 2012. [Internet] Available at: www.ucalgary.ca/~patten/blackwelder.html webcite
• [23]Norman WV, Kaczorowski J, Soon JA, Brant R, Bryan S, Trouton K, Dicus L: Immediate vs. Delayed Insertion of Intrauterine Contraception after Second Trimester Abortion: Study Protocol for a Randomized Controlled Trial. Trials 2011, 12:149. http://www.trialsjournal.com/content/12/1/149 webcite PUBMED id: 21672213
• [24]Norman WV: The Better Contraceptive Choices Studies: Contraception and Abortion Research Team. Accessed July 25 2012. web site. [Internet] Available at: https://www.bcc4me.ca/study2.aspx webcite
• [25]Colwell HH, Mathias SD, Cimms TA, Rothman M, Friedman AJ, Patrick DL: The ORTHO BC-SAT – a satisfaction questionnaire for women using hormonal contraceptives. Qual Life Res 2006, 15:1621-1631.
• [26]Mathias SD, Colwell HH, LoCoco JM, et al.: ORTHO birth control satisfaction assessment tool: assessing sensitivity to change and predictors of satisfaction. Contraception 2006, 74:303-308.
• [27]Willan AR: Randomize.net [internet]. Biometrix Helath Research Services, Inc, Ottawa; 2012. Available from: http://www.randomize.net/index.html webcite
• [28]Montgomery CA, Norman WV, Money DM, Rekart ML: Antibiotic prophylaxis at the time of induced abortion. BC Medical J 2002, 44(7):367-373. Available at: http://www.bcmj.org/article/antibiotic-prophylaxis-time-induced-abortion webcite
• [29]The Society of Family Planning: Research and Grants. Society of Family Planning Web Site. 2012. [Internet] Available at: http://www.societyfp.org/research/applying.asp webcite