Immediate Versus Delayed Insertion of the Copper IUD After Second-trimester Medical Abortion - a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 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
研究组 & 干预措施
Immediate group:
The Copper Intrauterine device will be inserted within 24 hours of the expulsion of the fetus and placenta or after surgical evacuation for placental remains, and prior to discharge from the facility.
干预措施: Copper Intrauterine device (Device)
Delayed Group
The Copper Intrauterine device will be inserted at a local community health centre 14-28 days after discharge.
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)
- Spontaneous expulsion of the IUD(6 weeks post-abortion)
- Spontaneous expulsion of the IUD(Between 6 weeks and 3 months post abortion)
研究者
Deborah Constant, Dr
Senior Researcher
University of Cape Town