Better Contraceptive Choices: Immediate or Delayed Insertion of IUC After Second Trimester Abortion
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|ClinicalTrials.gov Identifier: NCT00877344|
Recruitment Status : Active, not recruiting
First Posted : April 7, 2009
Last Update Posted : May 4, 2018
Intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current standard practice of intended placement at 4 weeks post-abortion.
Randomized Controlled Trial after their second trimester abortion comparing immediate with delayed insertion of IUC, and a non intervention control group choosing non-intrauterine contraception. Participants choosing an IUC will be randomly assigned to immediate or delayed insertion. The investigators primary outcome is pregnancy rate within one year.
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Procedure: Immediate insertion Procedure: Interval insertion||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||534 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study uses a drug, but as the study is conducted in Canada the FDA approval is not required. We have approval (a Letter of No Objection) from the Canadian Equivalent Institution: "Health Canada"|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The assessment of outcomes (pregnancy conceived within one year) will be assessed through documentation of pregnancy in health administrative data.|
|Official Title:||Better Contraceptive Choices: Immediate vs. Delayed Insertion of Intrauterine Contraception After Second Trimester Abortion|
|Study Start Date :||June 2009|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2020|
Immediate insertion of either a LNG-IUC or a Copper T380 IUD after 12-24 week abortion
Procedure: Immediate insertion
Immediate timing of insertion for a LNG-IUC OR Copper 380mg T-shaped IUD after an abortion for a gestational age between 12 weeks zero days and 23 weeks 6 days. Immediate insertions occur during the visit for the abortion immediately after the abortion is complete, interval insertions will be scheduled for not earlier than two weeks and not later than four weeks after the abortion.
Interval insertion (two to four weeks post abortion) of either a LNG-IUC or a Copper T380 IUD after 12-24 abortion
Procedure: Interval insertion
Interval Timing of insertion for a LNG-IUC OR Copper 380mg T-shaped IUD after an abortion for a gestational age between 12 weeks zero days and 23 weeks 6 days. Immediate insertions occur during the visit for the abortion immediately after the abortion is complete, interval insertions will be scheduled for not earlier than two weeks and not later than four weeks after the abortion.
- Pregnancy rate at one year [ Time Frame: 12 months ]The one year pregnancy rate outcome will be determined using a pragmatic approximation based on the varying exactitude of imputations based on provincial Medical Service Plan billings related to abortions, miscarriages, still births and live births. Subsequent abortions performed within our study clinics for enrolled participants will be noted along with specific clinical information on pregnancy duration. For abortions performed elsewhere such as those for BC university students studying out of province, or those performed by individual physicians at rural or remote hospitals within BC, exact gestation may not be available. In the BC health administrative databases abortions are billed as under 7 weeks for medical abortions, and as under 14 weeks, 14 weeks to under 18 weeks, and 18 weeks and over for surgical abortions. Miscarriages by definition occur anytime under 20 weeks or are classed as still birth when over 20 weeks of gestation.
- Rates at one year for Expulsion, Continuation of use, Satisfaction with method, Adverse events. [ Time Frame: 60 months ]Secondary outcomes will be assessed initially at one year, then annually through the five year device effectiveness period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877344
|Canada, British Columbia|
|Kelowna General Hospital Women's Services Clinic|
|Kelowna, British Columbia, Canada|
|BC Women's Hospital|
|Vancouver, British Columbia, Canada|
|Elizabeth Bagshaw Women's Clinic|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||Wendy V. Norman, Ph.D||University of British Columbia|
|Study Director:||Brian Fitzsimmons, MD||University of British Columbia|
|Study Chair:||Lyda Dicus||University of British Columbia|