Better Contraceptive Choices: Immediate vs. Delayed Insertion of Intrauterine Contraception After Second Trimester Abortion
试验速览
- 阶段
- 4 期
- 入组人数
- 474
- 试验地点
- 3
- 主要终点
- Pregnancy rate at one year
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessment of outcomes (pregnancy conceived within one year) will be assessed through documentation of pregnancy in health administrative data.
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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
结局指标
主要结局
Pregnancy rate at one year
时间窗: 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.
次要结局
- Rates at one year for Expulsion, Continuation of use, Satisfaction with method, Adverse events.(60 months)
研究者
Wendy Norman
Principle Investigator
University of British Columbia