Pregnancy
Conditions
Keywords
Pregnancy, IUC, abortion, contraception
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.
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.
Interventions
PROCEDUREImmediate 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.
PROCEDUREInterval 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.
Sponsors
Women's Health Research Institute of British Columbia
College of Family Physicians of Canada
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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.
Intervention model description
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
Eligibility
Sex/Gender
FEMALE
Age
10 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate at one year | 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
| Measure | Time frame | Description |
|---|---|---|
| Rates at one year for Expulsion, Continuation of use, Satisfaction with method, Adverse events. | 60 months | Secondary outcomes will be assessed initially at one year, then annually through the five year device effectiveness period. |
Countries
Canada
Outcome results
None listed