NCT03505047已完成不适用
Immediate Versus Delayed Insertion of the Copper IUD After Second-trimester Medical Abortion - a Randomised Controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Insertion of the IUD
研究概览
简要总结
The main objective of the study is to compare use, in a randomised controlled trial, of the the copper IUD if inserted immediately after completion of a second trimester medical abortion, to standard care with insertion 3-4 or more weeks after abortion at community health centres.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to speak English, Afrikaans or Xhosa;
- •Requesting and eligible for abortion according to standard practice at the hospital;
- •Gestational age 13-20 weeks verified by ultrasound;
- •Interested and eligible for the copper IUD as a post-abortion contraceptive method;
- •Willingness to participate in the trial including follow-up;
- •Able to provide a working phone & telephone number to allow for contact;
- •Willing and able to provide informed consent
- •Staying within one hour travel time of GSH
排除标准
- •Active pelvic inflammatory disease, pelvic tuberculosis; severe thrombocytopenia;
- •Positive N. Gonorrhea or C. Trachomatis that has not been adequately treated
- •Copper allergy
- •Hb <10g/dL
- •Uterine anomaly preventing placement of the IUD; cervical cancer or carcinoma in-situ, untreated high grade squamous intraepithelial lesions
- •Hemorrhage; or ruptured uterus
- •History of ectopic pregnancy
- •Wilsons' disease
结局指标
主要结局
Insertion of the IUD
时间窗: 6 weeks after second trimester abortion
Number of IUD insertions
Use of the copper IUD
时间窗: 6 weeks after second trimester abortion
Number of women using the IUD
次要结局
- Women's satisfaction and acceptability of the IUD(Reported at 3 and 6 months post-abortion)
- Recurrent pregnancy(At 6 months post-abortion)
- Use of the IUD at 6 months post-abortion(6 months after second trimester medical abortion)
- Spontaneous expulsion of the IUD(Between 3 and 6 months post abortion)
- Use of the IUD at 3 months post-abortion(3 months after second trimester medical abortion)
- Removal of IUD and associated factors(within 3 and 6 months post-abortion)
- Abortion-related and IUD-related complications(within 3 months post-abortion)
研究者
Deborah Constant, Dr
Senior Researcher
University of Cape Town
研究点 (2)
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