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

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ClinicalTrials.gov Identifier: NCT00877344
Recruitment Status : Active, not recruiting
First Posted : April 7, 2009
Last Update Posted : May 4, 2018
Sponsor:
Collaborators:
Women's Health Research Institute of British Columbia
College of Family Physicians of Canada
Information provided by (Responsible Party):
Wendy Norman, University of British Columbia

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.


Condition or disease Intervention/treatment Phase
Pregnancy Procedure: Immediate insertion Procedure: Interval insertion Phase 4

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  (Clinical Trial)
Actual Enrollment : 534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study uses a drug, 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"
Masking: Single (Outcomes Assessor)
Masking Description: The assessment of outcomes (pregnancy conceived within one year) will be assessed through documentation of pregnancy in health administrative data.
Primary Purpose: Prevention
Official Title: Better Contraceptive Choices: Immediate vs. Delayed Insertion of Intrauterine Contraception After Second Trimester Abortion
Study Start Date : June 2009
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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.




Primary Outcome Measures :
  1. Pregnancy rate at one year [ Time Frame: 12 months ]
    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.


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



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 of Canada
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

Responsible Party: Wendy Norman, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT00877344     History of Changes
Other Study ID Numbers: H09-00363
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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