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document
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 . 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 .
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Intervention_Physical
copper intrauterine devices
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Intervention_Physical
FlexiT
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Intervention_Physical
NovaT
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Intervention_Physical
Flexi-T380 ( + ) copper intrauterine contraceptive device ( IUD )
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Intervention_Physical
Flexi-T380 ( + ) IUD
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Intervention_Physical
Nova-T200 IUD
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Outcome_Mental
IUD expulsion rate at 1 year
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Outcome_Mental
pregnancy rate
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Outcome_Mental
method continuation rate
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Outcome_Physical
complication rates ( infection , perforation )
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Outcome_Other
satisfaction
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Outcome_Mental
expulsion rate
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Outcome_Other
pregnancy rate
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Outcome_Other
method satisfaction
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Participant_Condition
first-trimester abortion
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Participant_Sex
women
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Participant_Condition
an IUD after an abortion for a pregnancy of less than 12 weeks of gestation