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

NCT00877344 | Unknown Phase 4

• 1 other identifier: H09-00363
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 3

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.

Conditions

Pregnancy

Keywords

Pregnancy; IUC; abortion; contraception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rates at one year for Expulsion, Continuation of use, Satisfaction with method, Adverse events.

  60 months

Study Arms (2)

1

EXPERIMENTAL

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

Procedure: Immediate insertion

2

EXPERIMENTAL

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

Interventions

Immediate insertion 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.

1

Interval insertion 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.

2

Eligibility Criteria

• Age: 10 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Have completed informed consent for an abortion at gestation between 12 weeks zero days and 23 weeks 6 days, and
• Choosing an IUC (either LNG-IUC or CuT380-IUC) for contraception post abortion, and
• Residents of British Columbia, registered with the Medical Services Plan health care system.

You may not qualify if:

• Intention to move from BC within the next year
• Intention to conceive within the next year.
• Any of the following contraindications to use of a LNG-IUC or a CuT380-IUC
• uterine perforation at the time of abortion
• bleeding of more than 500 cc during abortion

Sponsors & Collaborators

• University of British Columbia: lead
• Women's Health Research Institute of British Columbia: collaborator
• College of Family Physicians of Canada: collaborator

Study Sites (3)

Kelowna General Hospital Women's Services Clinic

Kelowna, British Columbia, Canada

Location

BC Women's Hospital

Vancouver, British Columbia, Canada

Location

Elizabeth Bagshaw Women's Clinic

Vancouver, British Columbia, Canada

Location

Study Officials

• Wendy V. Norman, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Brian Fitzsimmons, MD

  University of British Columbia

  STUDY DIRECTOR

• Lyda Dicus

  University of British Columbia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessment of outcomes (pregnancy conceived within one year) will be assessed through documentation of pregnancy in health administrative data.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: This study uses a drug (levonorgestrel-releasing intrauterine contraception ("Mirena" (R)), but as the study is conducted in Canada the FDA approval is not required. We have approval (a Letter of No Objection) from the Canadian Equivalent Institution: "Health Canada"

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 7, 2009
• Study Start: June 1, 2009
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)