Mifepristone and Misoprostol Versus Misoprostol Alone for Treatment of Fetal Death at 14-28 Weeks of Pregnancy: A Randomized, Placebo-controlled Double-blinded Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Complete uterine evacuation of the fetus and placenta without surgical intervention
研究概览
简要总结
The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP.
详细描述
The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP. This will be a randomized controlled double-blinded trial of 150 women comparing misoprostol alone to mifepristone plus misoprostol for evacuation of the uterus after fetal demise in the second and third trimester. All women in the trial will undergo routine screening 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:
- STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours;
- STUDY GROUP TWO: placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.
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 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Demised fetus of between 14 to 28 weeks duration confirmed by ultrasound
- •Have no contraindications to study procedure, according to provider
- •Be able to consent to procedure, either by reading consent document or by having consent document read to her
- •Be willing to follow study procedures.
排除标准
- •Allergies or other contraindications to the use of mifepristone or misoprostol;
- •Placental abruption with active hemorrhage,
- •Complete placenta previa, extreme uterine structural anomalies, or other contradictions to vaginal delivery of the fetus;
- •Presentation in active labor (moderate to severe contractions every 10 minutes or less);
- •Transmural uterine scars;
- •Four or more previous deliveries.
研究组 & 干预措施
Group 1
200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours
干预措施: Mifepristone (Drug)
Group 1
200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours
干预措施: Misoprostol 200mcg (Drug)
Group 2
placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.
干预措施: Placebo (Drug)
Group 2
placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.
干预措施: Misoprostol 200mcg (Drug)
结局指标
主要结局
Complete uterine evacuation of the fetus and placenta without surgical intervention
时间窗: 48 hours
Complete uterine evacuation of fetus and placenta using study drug alone without recourse to any additional surgical intervention
次要结局
未报告次要终点