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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Women's Health Research Institute of British Columbia
College Of Family Physicians
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00877344
First received: April 3, 2009
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Pregnancy
Device: LNG-IUC or Copper T380
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Better Contraceptive Choices: Immediate vs. Delayed Insertion of Intrauterine Contraception After Second Trimester Abortion

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Pregnancy rate at one year [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates at one year for Expulsion, Continuation of use, Satisfaction with method, Adverse events. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 716
Study Start Date: September 2011
Estimated Study Completion Date: December 2017
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Immediate insertion of IUC after 12-24 week abortion
Device: 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: 2
Interval (two to four weeks post abortion) insertion of IUC after 12-24 abortion
Device: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877344

Locations
Canada, British Columbia
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
Sponsors and Collaborators
University of British Columbia
Women's Health Research Institute of British Columbia
College Of Family Physicians
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
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00877344     History of Changes
Other Study ID Numbers: H09-00363
Study First Received: April 3, 2009
Last Updated: January 29, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Pregnancy
IUC
abortion
contraception

Additional relevant MeSH terms:
Contraceptive Agents
Copper
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014