IUD Insertion Post First Trimester Abortion

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01174225
First received: July 30, 2010
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Contraception
Device: Flexi T 380(+) IUD
Device: Nova T IUD
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Contraception Satisfaction and Effectiveness: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The expulsion rate of each IUD [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The expulsion rate of each IUD and the scaled measure of patient satisfaction with each form of contraception (completed July 2012)


Secondary Outcome Measures:
  • Voluntary discontinuation rate of contraception [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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)



Estimated Enrollment: 750
Study Start Date: September 2010
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174225

Locations
Canada, British Columbia
Kelowna Womens' Clinic
Kelowna, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Society of Family Planning
Investigators
Principal Investigator: Wendy V Norman, MD, FCFP, DTM&H, MHSc University of British Columbia
  More Information

Additional Information:
No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01174225     History of Changes
Other Study ID Numbers: H10-00798
Study First Received: July 30, 2010
Last Updated: January 29, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Copper IUD
Nova T 200
Flexi T 380
expulsion
contraception satisfaction
post-abortion contraception

ClinicalTrials.gov processed this record on July 29, 2014