IUD Insertion Post First Trimester Abortion

Contraception Clinical Trial

Official title:

Contraception Satisfaction and Effectiveness: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01174225
• Other study ID #: H10-00798
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 2010
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 534
• Est. completion date: June 30, 2023
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Kelowna Womens' Clinic	Kelowna	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Society of Family Planning

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The expulsion rate of each IUD	The expulsion rate of each IUD and the scaled measure of patient satisfaction with each form of contraception (completed July 2012)	12 months
Secondary	Voluntary discontinuation rate of contraception	Voluntary 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)	12 months

External Links

•   This website is the site for the Research Team and summarizes current studies