Overview

This trial is active, not recruiting.

Condition pregnancy
Treatments lng-iuc or copper t380
Phase phase 4
Sponsor University of British Columbia
Collaborator Women's Health Research Institute of British Columbia
Start date June 2009
End date June 2018
Trial size 534 participants
Trial identifier NCT00877344, H09-00363

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Immediate insertion of IUC after 12-24 week abortion
lng-iuc or copper t380
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.
(Experimental)
Interval (two to four weeks post abortion) insertion of IUC after 12-24 abortion
lng-iuc or copper t380
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.

Primary Outcomes

Measure
Pregnancy rate at one year
time frame: 12 months

Secondary Outcomes

Measure
Rates at one year for Expulsion, Continuation of use, Satisfaction with method, Adverse events.
time frame: 12 months

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Better Contraceptive Choices: Immediate vs. Delayed Insertion of Intrauterine Contraception After Second Trimester Abortion
Principal investigator Wendy V. Norman, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of British Columbia.