Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
534 participants
INTERVENTIONAL
2010-09-30
2023-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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I
Participants who elect to have an IUD inserted at the time of abortion will be randomized to either Arm I or Arm II. In this arm participants will receive the Flexi T 380(+) IUD. The participant is counseled that she may leave the device in for up to five years. She will be followed for up to five years to determine expulsion rate, discontinuation rate, pregnancy rate, and overall satisfaction with form of contraception.
Flexi T 380(+) IUD
The intrauterine device is placed in the uterus immediately post-abortion. Participant is counseled that she may leave the device in for up to five years.
II
Participants who elect to have an IUD inserted at the time of abortion will be randomized to either Arm I or Arm II. In this arm participants will receive the Nova T IUD. The participant is counseled that she may leave the device in for up to five years. She will be followed for up to five years to determine expulsion rate, discontinuation rate, pregnancy rate, and overall satisfaction with form of contraception.
Nova T IUD
The intrauterine device is placed in the uterus immediately post-abortion. Participant is counseled that she may leave the device in for up to five years.
III
Participants who elect for forms of contraception other than a copper IUD will chose which form of contraception they would like to use and be put into one of the groups specified below based on her contraceptive choice. These participants will be observed throughout the study for overall satisfaction and repeat pregnancy rate.
Groups - Participants will be in one of the five following groups Group A - Oral contraceptive pill 28day supply provided after abortion Group B - Medroxyprogesterone acetate (Depo-provera)150mg IM provided after abortion, lasts for 3 months Group C - Ethinyl estradiol and etonogestrel (Nuva ring) provided at time of abortion, lasts for 28 days Group D - Condoms provided at time of abortion Group E - Other
No interventions assigned to this group
Interventions
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Flexi T 380(+) IUD
The intrauterine device is placed in the uterus immediately post-abortion. Participant is counseled that she may leave the device in for up to five years.
Nova T IUD
The intrauterine device is placed in the uterus immediately post-abortion. Participant is counseled that she may leave the device in for up to five years.
Eligibility Criteria
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Inclusion Criteria
* Women seeking abortions for pregnancies up to 11 weeks 6 days gestation
Exclusion Criteria
FEMALE
Yes
Sponsors
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Society of Family Planning
OTHER
University of British Columbia
OTHER
Responsible Party
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Wendy Norman
Principle Investigator
Principal Investigators
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Wendy V Norman, MD, FCFP
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Kelowna Womens' Clinic
Kelowna, British Columbia, Canada
Countries
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References
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Samiedaluie S, Peterson S, Brant R, Kaczorowski J, Norman WV. Validating abortion procedure coding in Canadian administrative databases. BMC Health Serv Res. 2016 Jul 12;16:255. doi: 10.1186/s12913-016-1485-4.
Norman WV, Chiles JL, Turner CA, Brant R, Aslan A, Kaczorowski J. 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. Trials. 2012 Aug 24;13:147. doi: 10.1186/1745-6215-13-147.
Related Links
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This website is the site for the Research Team and summarizes current studies
Other Identifiers
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H10-00798
Identifier Type: -
Identifier Source: org_study_id
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