IUD Insertion Post First Trimester Abortion

NCT01174225 | Unknown Phase 4 DMC

• 1 other identifier: H10-00798
• Study Type: interventional
• Target: 534
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Voluntary discontinuation rate of contraception

  12 months

Study Arms (3)

I

ACTIVE COMPARATOR

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

II

ACTIVE COMPARATOR

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

III

NO INTERVENTION

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

Interventions

Flexi T 380(+) IUD DEVICE

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.

I

Nova T IUD DEVICE

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.

II

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Residents of BC registered with the Medical Services Plan of British Columbia
• Women seeking abortions for pregnancies up to 11 weeks 6 days gestation

You may not qualify if:

• Women who plan to conceive within the next year

Sponsors & Collaborators

• University of British Columbia: lead
• Society of Family Planning: collaborator

Study Sites (1)

Kelowna Womens' Clinic

Kelowna, British Columbia, Canada

Location

Related Publications (2)

• 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.

  PMID: 27406214 DERIVED

• 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.

  PMID: 22920273 DERIVED

Related Links

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

MeSH Terms

Interventions

Intrauterine Devices

Intervention Hierarchy (Ancestors)

Contraceptive Devices, Female; Contraceptive Devices; Equipment and Supplies

Study Officials

• Wendy V Norman, MD, FCFP

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Flexi-T380(+) IUD Nova-T200 IUD

Study Record Dates

• First Submitted: July 30, 2010
• First Posted: August 3, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: June 30, 2023
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)