IUD Insertion Post First Trimester Abortion

May 19, 2022 updated by: Wendy Norman, University of British Columbia

Contraception Satisfaction and Effectiveness: A Randomized Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

534

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Kelowna Womens' Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Active Comparator: 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.
Device: 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.
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The expulsion rate of each IUD
Time Frame: 12 months
The expulsion rate of each IUD and the scaled measure of patient satisfaction with each form of contraception (completed July 2012)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voluntary discontinuation rate of contraception
Time Frame: 12 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Wendy V Norman, MD, FCFP, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

July 30, 2010

First Submitted That Met QC Criteria

August 2, 2010

First Posted (Estimate)

August 3, 2010

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H10-00798

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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