Better Contraceptive Choices: Immediate or Delayed Insertion of IUC After Second Trimester Abortion

NCT ID: NCT00877344

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2023-06-30

Brief Summary

Hypothesis

Intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current standard practice of intended placement at 4 weeks post-abortion.

Study Design

Randomized Controlled Trial after their second trimester abortion comparing immediate with delayed insertion of IUC, and a non intervention control group choosing non-intrauterine contraception. Participants choosing an IUC will be randomly assigned to immediate or delayed insertion. The investigators primary outcome is pregnancy rate within one year.

Detailed Description

This Randomized Controlled Trial will be offered to women choosing to have a LNG-IUC or CuT380 after an abortion for gestational ages from 12 to 24 weeks. [delete next insert]"and a non intervention control group offered to all others having abortions at this gestational age". Participants choosing an LNG-IUC or CUT380 will be randomly assigned to immediate or interval insertion. In conjunction with follow up visits and questionnaires, the British Columbia Linked Health Database access will determine pregnancy rate within one year for the two intervention groups [delete next insert] and in relation to the various contraceptive choices made by the women not choosing intrauterine contraception. All women will complete surveys at 3, 6, 12, 24, 36, 48 and 72 months on their satisfaction with the contraceptive method chosen and on their satisfaction with study participation.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Immediate insertion of either a LNG-IUC or a Copper T380 IUD after 12-24 week abortion

Group Type: EXPERIMENTAL

Immediate insertion

Intervention Type: PROCEDURE

Immediate timing of insertion for a LNG-IUC OR Copper 380mg T-shaped IUD after an abortion for a gestational age between 12 weeks zero days and 23 weeks 6 days. Immediate insertions occur during the visit for the abortion immediately after the abortion is complete, interval insertions will be scheduled for not earlier than two weeks and not later than four weeks after the abortion.

2

Interval insertion (two to four weeks post abortion) of either a LNG-IUC or a Copper T380 IUD after 12-24 abortion

Group Type: EXPERIMENTAL

Interval insertion

Intervention Type: PROCEDURE

Interval Timing of insertion for a LNG-IUC OR Copper 380mg T-shaped IUD after an abortion for a gestational age between 12 weeks zero days and 23 weeks 6 days. Immediate insertions occur during the visit for the abortion immediately after the abortion is complete, interval insertions will be scheduled for not earlier than two weeks and not later than four weeks after the abortion.

Interventions

Immediate insertion

Immediate timing of insertion for a LNG-IUC OR Copper 380mg T-shaped IUD after an abortion for a gestational age between 12 weeks zero days and 23 weeks 6 days. Immediate insertions occur during the visit for the abortion immediately after the abortion is complete, interval insertions will be scheduled for not earlier than two weeks and not later than four weeks after the abortion.

Intervention Type: PROCEDURE

Interval insertion

Interval Timing of insertion for a LNG-IUC OR Copper 380mg T-shaped IUD after an abortion for a gestational age between 12 weeks zero days and 23 weeks 6 days. Immediate insertions occur during the visit for the abortion immediately after the abortion is complete, interval insertions will be scheduled for not earlier than two weeks and not later than four weeks after the abortion.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Have completed informed consent for an abortion at gestation between 12 weeks zero days and 23 weeks 6 days, and

2. Choosing an IUC (either LNG-IUC or CuT380-IUC) for contraception post abortion, and

3. Residents of British Columbia, registered with the Medical Services Plan health care system.

Exclusion Criteria

1. Intention to move from BC within the next year

2. Intention to conceive within the next year.

3. Any of the following contraindications to use of a LNG-IUC or a CuT380-IUC

4. Post Randomization Exclusion:

uterine perforation at the time of abortion

bleeding of more than 500 cc during abortion

any of the above exclusions detected at time of abortion

• Minimum Eligible Age: 10 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Women's Health Research Institute of British Columbia

OTHER

Sponsor Role: collaborator

College of Family Physicians of Canada

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Wendy Norman

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wendy V. Norman, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Brian Fitzsimmons, MD

Role: STUDY_DIRECTOR

University of British Columbia

Lyda Dicus

Role: STUDY_CHAIR

University of British Columbia

Locations

Kelowna General Hospital Women's Services Clinic

Kelowna, British Columbia, Canada

BC Women's Hospital

Vancouver, British Columbia, Canada

Elizabeth Bagshaw Women's Clinic

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H09-00363

Identifier Type: -

Identifier Source: org_study_id