Better Contraceptive Choices: Immediate or Delayed Insertion of IUC After Second Trimester Abortion
This trial is active, not recruiting.
|Treatments||lng-iuc or copper t380|
|Sponsor||University of British Columbia|
|Collaborator||Women's Health Research Institute of British Columbia|
|Start date||June 2009|
|End date||September 2016|
|Trial size||534 participants|
|Trial identifier||NCT00877344, H09-00363|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Kelowna, Canada||Kelowna General Hospital Women's Services Clinic||no longer recruiting|
|Vancouver, Canada||BC Women's Hospital||no longer recruiting|
|Vancouver, Canada||Elizabeth Bagshaw Women's Clinic||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Pregnancy rate at one year
time frame: 12 months
Rates at one year for Expulsion, Continuation of use, Satisfaction with method, Adverse events.
time frame: 12 months
Female participants at least 18 years old.
Inclusion Criteria: 1. Have completed informed consent for an abortion at gestation between 12 weeks zero days and 23 weeks 6 days, and 2. Choosing an IUC (either LNG-IUC or CuT380-IUC) for contraception post abortion, and 3. Residents of British Columbia, registered with the Medical Services Plan health care system. Exclusion Criteria: 1. Intention to move from BC within the next year 2. Intention to conceive within the next year. 3. Any of the following contraindications to use of a LNG-IUC or a CuT380-IUC 4. Post Randomization Exclusion: uterine perforation at the time of abortion bleeding of more than 500 cc during abortion any of the above exclusions detected at time of abortion
|Official title||Better Contraceptive Choices: Immediate vs. Delayed Insertion of Intrauterine Contraception After Second Trimester Abortion|
|Principal investigator||Wendy V. Norman, Ph.D|
|Description||This Randomized Controlled Trial will be offered to women choosing to have a LNG-IUC or CuT380 after an abortion for gestational ages from 12 to 24 weeks. [delete next insert]"and a non intervention control group offered to all others having abortions at this gestational age". Participants choosing an LNG-IUC or CUT380 will be randomly assigned to immediate or interval insertion. In conjunction with follow up visits and questionnaires, the British Columbia Linked Health Database access will determine pregnancy rate within one year for the two intervention groups [delete next insert] and in relation to the various contraceptive choices made by the women not choosing intrauterine contraception. All women will complete surveys at 3, 6, 12, 24, 36, 48 and 72 months on their satisfaction with the contraceptive method chosen and on their satisfaction with study participation.|
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