Clinical trial NCT01174225: IUD Insertion Post First Trimester Abortion
Official title: Contraception Satisfaction and Effectiveness: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Contraception
Keywords: Copper IUD
Nova T 200
Flexi T 380
expulsion
contraception satisfaction
post-abortion contraception
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2010-08-03
Enrollment: 534
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Flexi-T380(+) IUD Nova-T200 IUD
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The expulsion rate of each IUD
timeFrame: 12 months
Secondary outcomes:
measure: Voluntary discontinuation rate of contraception
timeFrame: 12 months
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Kelowna Womens' Clinic
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Wendy V Norman, MD, FCFP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.