Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 416
- 试验地点
- 4
- 主要终点
- Rate of successful evacuation of the uterus
研究概览
简要总结
The purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.
详细描述
The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of missed abortion. This will be a randomized controlled double-blinded trial of 416 women comparing misoprostol alone to mifepristone plus misoprostol for treatment of missed abortion less than 13 weeks+ 0 days LMP. All women in the trial will undergo routine screening (including ultrasound) and pre-medical induction care per standard practice at the hospital. All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens: 1) STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by 800mcg sublingual misoprostol; 2) STUDY GROUP TWO: placebo followed in 24 hours by 800mcg sublingual misoprostol.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ultrasound examination demonstrating:
- •Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR
- •Empty gestational sac with no evidence of incomplete abortion or growth over a 7-day period confirmed by two ultrasounds performed one week apart.
- •If fetus exists, fetal size less than 12 weeks+6 days
- •Closed cervical os
- •Eligible to consent for research according to local regulations
排除标准
- •Active bleeding at enrollment and/or history of bleeding within the prior week
- •Allergies or other contraindications to the use of mifepristone or misoprostol
- •Suspected ectopic pregnancy
- •History of trophoblastic disease
- •Coagulation disorder and/or currently taking anticoagulants
- •Any serious medical condition
研究组 & 干预措施
Mifepristone-misoprostol regimen
After a woman is determined eligible and signs the informed consent document, she will receive 200 mg mifepristone and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.
干预措施: Mifepristone (Drug)
Mifepristone-misoprostol regimen
After a woman is determined eligible and signs the informed consent document, she will receive 200 mg mifepristone and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.
干预措施: Misoprostol (Drug)
Misoprostol alone regimen
After a woman is determined eligible and signs the informed consent document, she will receive a placebo (of same shape and size of mifepristone) and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Rate of successful evacuation of the uterus
时间窗: 1 week after treatment
uterine evacuation without the need for uterine aspiration or other surgery
次要结局
- Induction expulsion interval after misoprostol administration(one week follow-up)
- Acceptability of assigned method to women(one week follow-up)
- Rate of successful evacuation without any additional intervention(1 week after treatment)
- Excessive bleeding or a complication for which a woman received treatment(30 days after treatment)