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Open Access Study protocol

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

Wendy V Norman123*, Jessica L Chiles12, Caroline A Turner12, Rollin Brant14, Andra Aslan12 and Janusz Kaczorowski15

Author Affiliations

1 Contraception Access Research Team, Women’s Health Research Institute, Vancouver, British Columbia, V6H 1G3, Canada

2 Department of Family Practice, University of British Columbia, Vancouver, British Columbia, V6T 1Z3, Canada

3 School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, V6T 1Z3, Canada

4 Department of Statistics, University of British Columbia, Vancouver, British Columbia, V6H 3V4, Canada

5 Département de médecine familiale et médecine d’urgence, L’Université de Montréal, Montréal, Quebec, Canada

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Trials 2012, 13:147  doi:10.1186/1745-6215-13-147

Published: 24 August 2012

Abstract

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

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