IUD Insertion Post First Trimester Abortion
This trial is active, not recruiting.
|Treatments||flexi t 380(+) iud, nova t iud|
|Sponsor||University of British Columbia|
|Collaborator||Society of Family Planning|
|Start date||September 2010|
|End date||September 2013|
|Trial size||534 participants|
|Trial identifier||NCT01174225, H10-00798|
The goal of this study is to provide better information about contraception to women having an abortion so that they are less likely to have another unintended unwanted pregnancy.
Participating subjects will receive their choice of contraception following their abortion and if this choice is an IUD they will be randomly assigned to one of two types of copper intrauterine devices.
All participating women will fill out a survey about their contraceptive choices at the time of their abortion as well as at 3, 6, and 12 months afterwards. The investigators will also follow pregnancy rates at 1 through 5 years after the abortion to see which form of contraception was most effective.
The investigators expect to find that IUDs are the most effective form of contraception but that the types of copper IUDs currently available in Canada are not known to be as effective as those available in other countries, for which high quality evidence is available. The investigators hope to use this data to determine the effectiveness of copper IUDs available in Canada.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
The expulsion rate of each IUD
time frame: 12 months
Voluntary discontinuation rate of contraception
time frame: 12 months
Female participants of any age.
Inclusion Criteria: - Residents of BC registered with the Medical Services Plan of British Columbia - Women seeking abortions for pregnancies up to 11 weeks 6 days gestation Key Exclusion Criteria: - Women who plan to conceive within the next year
|Official title||Contraception Satisfaction and Effectiveness: A Randomized Controlled Trial|
|Principal investigator||Wendy V Norman, MD, FCFP, DTM&H, MHSc|
|Description||This prospective randomized controlled trial will examine satisfaction and effectiveness of post abortion contraception by comparing the two types of copper IUDs currently available in Canada, and including a non-interventional group of other contraceptive options. The primary outcome measure is one year expulsion rates of copper IUDs places post abortion. Secondary outcomes are satisfaction with current method at 3, 6, and 12 months post-abortion, retention rates and repeat abortion rate over one year. One and five year pregnancy rates will be analyzed using access to universal health care databases. Our results will provide the first information on the effectiveness of post abortion contraceptive methods currently available in Canada.|
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