Preventing Future Pregnancy After Choosing the Copper IUD vs. Oral Levonorgestrel for Emergency Contraception
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 548
- 试验地点
- 2
- 主要终点
- Unplanned pregnancy
研究概览
简要总结
The purpose of this study is to see if women presenting for emergency contraception (EC) and choose the copper intrauterine device (IUD) will have fewer unplanned pregnancies in the next year compared to women who choose oral levonorgestrel for EC. The study will also compare use of an effective method of contraception in the year after they received EC.
详细描述
All women presenting to 2 Planned Parenthood Association of Utah clinics in Salt Lake City will be offered participation in this study. Women will select either the copper IUD or oral levonorgestrel for EC. The primary outcome is unplanned pregnancy in the year following presentation for EC.
Secondary outcomes include use of an effective method of contraception over the next year, abortions, repeat use of EC, number of days to first bleeding episode and duration of that bleeding episode, use of a barrier method to prevent sexually transmitted infections, patient satisfaction with the chosen method of EC and contraception. Participants selecting the IUD will be assessed for IUD expulsion, perforation, and removal.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 18-30 years old,
- •in need of emergency contraception (had unprotected intercourse within 120 hours),
- •willing to give consent for participation in research,
- •willing to comply with study requirements, and
- •accessible by telephone.
- •Participants selecting the IUD need to identify themselves as desiring long-term contraception.
排除标准
- •Current pregnancy
- •Had pelvic inflammatory disease or septic abortion within the past 3 months or had gonorrhea or chlamydia infection in the last 60 days
- •Current behavior suggesting a high risk for pelvic inflammatory disease
- •Allergy to copper or Wilson's disease (for participants selecting the copper IUD) or allergy to levonorgestrel (for participants selecting oral levonorgestrel)
- •Abnormalities of the uterus that distort the uterine cavity
- •Mucopurulent cervicitis
- •A previously placed IUD that has not been removed
- •Genital bleeding of an unknown etiology
- •Ovarian, cervical, or endometrial cancer
- •Small uterine cavity (< 6cm)
研究组 & 干预措施
IUD
Women presenting for emergency contraception who select the copper IUD
干预措施: Copper T380 IUD (Drug)
Oral levonorgestrel
Women presenting for emergency contraception who select oral levonorgestrel
干预措施: Oral levonorgestrel (Drug)
结局指标
主要结局
Unplanned pregnancy
时间窗: within 12 months of presenting for EC
次要结局
- Use of an effective method of contraception in the year following use of emergency contraception.(12 months)
- IUD expulsion, removal or perforation(12 months)
研究者
David Turok
Clinical Assistant Professor
University of Utah