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

Better Contraceptive Choices: Immediate vs. Delayed Insertion of Intrauterine Contraception After Second Trimester Abortion

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Procedure: Immediate insertion; Procedure: Interval insertion

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.

• Study Type: Interventional
• Enrollment (Actual): 474
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada
      • Kelowna General Hospital Women's Services Clinic
    • Vancouver, British Columbia, Canada
      • BC Women's Hospital
    • Vancouver, British Columbia, Canada
      • Elizabeth Bagshaw Women's Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Immediate insertion of either a LNG-IUC or a Copper T380 IUD after 12-24 week abortion	Procedure: 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.
Experimental: 2; Interval insertion (two to four weeks post abortion) of either a LNG-IUC or a Copper T380 IUD after 12-24 abortion	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate at one year	The one year pregnancy rate outcome will be determined using a pragmatic approximation based on the varying exactitude of imputations based on provincial Medical Service Plan billings related to abortions, miscarriages, still births and live births. Subsequent abortions performed within our study clinics for enrolled participants will be noted along with specific clinical information on pregnancy duration. For abortions performed elsewhere such as those for BC university students studying out of province, or those performed by individual physicians at rural or remote hospitals within BC, exact gestation may not be available. In the BC health administrative databases abortions are billed as under 7 weeks for medical abortions, and as under 14 weeks, 14 weeks to under 18 weeks, and 18 weeks and over for surgical abortions. Miscarriages by definition occur anytime under 20 weeks or are classed as still birth when over 20 weeks of gestation.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates at one year for Expulsion, Continuation of use, Satisfaction with method, Adverse events.	Secondary outcomes will be assessed initially at one year, then annually through the five year device effectiveness period.	60 months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: College of Family Physicians of Canada; Women's Health Research Institute of British Columbia
• Investigators: Principal Investigator: Wendy V. Norman, Ph.D, University of British Columbia; Study Director: Brian Fitzsimmons, MD, University of British Columbia; Study Chair: Lyda Dicus, University of British Columbia

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: April 3, 2009
• First Submitted That Met QC Criteria: April 6, 2009
• First Posted (Estimate): April 7, 2009

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: Pregnancy; contraception; abortion; IUC
• Other Study ID Numbers: H09-00363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO