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IUD Insertion Post First Trimester Abortion

Contraception Satisfaction and Effectiveness: A Randomized Controlled Trial

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01174225
Enrollment
534
Registered
2010-08-03
Start date
2010-09-30
Completion date
2023-06-30
Last updated
2022-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Copper IUD, Nova T 200, Flexi T 380, expulsion, contraception satisfaction, post-abortion contraception

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.

Interventions

DEVICEFlexi 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.

DEVICENova 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.

Sponsors

Society of Family Planning
CollaboratorOTHER
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Flexi-T380(+) IUD Nova-T200 IUD

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The expulsion rate of each IUD12 monthsThe expulsion rate of each IUD and the scaled measure of patient satisfaction with each form of contraception (completed July 2012)

Secondary

MeasureTime frameDescription
Voluntary discontinuation rate of contraception12 monthsVoluntary discontinuation rate of contraception and one year rates of repeat abortion (completed July 2012) \- One and five year pregnancy rate for each form of contraception chosen (completed 2018)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026