NCT03479879已完成2 期
Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage: A Prospective, Double-blind, Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Duration of induction of abortion
研究概览
简要总结
To compare the effectiveness of estradiol pretreatment with misoprostol and vaginal misoprostol alone in induction of second trimestr miscarriage.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age more than 18 years old (age of legal consent).
- •Gestational age between 12-26 weeks.
- •Hb level > 10 g/dL.
- •BMI between 25 kg/m2 and 35 kg/m
- •Missed abortion.
- •Living fetus with multiple congenital malformations incompatible with life.
- •PPROMS with drained liquor and parents are consenting for termination of pregnancy.
排除标准
- •Maternal age less than 18 years old.
- •Gestational age less than 12 weeks or more than 26 weeks.
- •Hb level < 10 g/dL.
- •Scared uterus (previous myomectomy - cesarean section - hysterectomy and ruptured uterus).
- •Polyhydramnios.
- •Anencephaly.
- •Fibroid uterus.
- •BMI less than 25 kg/m2 and more than 35 kg/m
- •Coagulopathy.
- •Previous attempts for induction of abortion in the current pregnancy.
- •Allergy to misoprostol or estradiol.
- •Placenta previa.
- •Medical disorder that contraindicate induction of abortion (e.g. heart failure).
研究组 & 干预措施
Estradiol + Misoprostol
Experimental
干预措施: Estradiol (Drug)
Estradiol + Misoprostol
Experimental
干预措施: Misoprostol (Drug)
Placebo + Misoprostol
Placebo Comparator
干预措施: Placebo Oral Tablet (Drug)
Placebo + Misoprostol
Placebo Comparator
干预措施: Misoprostol (Drug)
结局指标
主要结局
Duration of induction of abortion
时间窗: 24 hours
次要结局
未报告次要终点
研究者
Mohamed S Sweed, MD
Principal Investigator
Ain Shams University
研究点 (1)
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