Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section: A Randomized, Double Blind Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Neonatal outcome
研究概览
简要总结
This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till December 2017. Group 1 women, candidates for cesarean section, will receive preoperative rectal 400 microgram of misoprostol, and Group 2 women will receive postoperative rectal 400 microgram of misoprostol.
- 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of misoprostol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients candidate for cesarean section.
- •Full term pregnancies (GA 37- 42 Wks).
- •Age (18-40 yrs).
- •body mass index (BMI) (20-30(Kg/m2 .
- •Exclusion Criteia:
- •Contraindication to spinal anesthesia.
- •Blood dyscrasias.
- •Large fibroids.
- •Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
- •Emergency CS such as fetal distress
- •Extreme of BMI (<20 or >30 Kg/m2 ).
排除标准
- 未提供
研究组 & 干预措施
Preoperative
Group no.1 will receive preoperative rectal 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative rectal placebo"2 tablets".
干预措施: Misoprostol (Drug)
Preoperative
Group no.1 will receive preoperative rectal 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative rectal placebo"2 tablets".
干预措施: Placebo (Other)
Postoperative
Group no.2 will receive preoperative rectal placebo "2 tablets" and postoperative rectal 400 microgram of misoprostol (Sigma) " 2 tablets" .
干预措施: Misoprostol (Drug)
Postoperative
Group no.2 will receive preoperative rectal placebo "2 tablets" and postoperative rectal 400 microgram of misoprostol (Sigma) " 2 tablets" .
干预措施: Placebo (Other)
结局指标
主要结局
Neonatal outcome
时间窗: 5 minutes
measured by APGAR score at 5 minutes
次要结局
- NICU admission(24 hours)
- amount of blood loss(24 hours)
- Postpartum hemorrhage(24 hours)
- Need for extra uterotonics(24 hours)
研究者
Mohamed S Sweed, MD
Assistant Professor
Ain Shams University