Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section: A Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Need for extra uterotonics
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 October 2017. 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 booked for elective cesarean section.
- •Singleton pregnancies.
- •Full term pregnancies (GA 37- 42 Wks).
- •Age (18-40 yrs).
- •body mass index (BMI) (20-30(Kg/m2 .
排除标准
- •Contraindication to spinal anesthesia.
- •Blood dyscrasias.
- •Large fibroids.
- •Multiple pregnancies.
- •Overdistended uterus eg. Hydramnios.
- •Pre-eclampsia.
- •Marked maternal anemia (Preoperative hemoglobin < 9 gm/dl).
- •Previous history of PPH.
- •Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
- •Placenta previa.
- •Previous myomectomy.
- •Extreme of BMI (<20 or >30 Kg/m2 ).
研究组 & 干预措施
Preoperative
• Group no.1 will receive preoperative sublingual 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative sublingual placebo"2 tablets".
干预措施: Misoprostol (Drug)
Preoperative
• Group no.1 will receive preoperative sublingual 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative sublingual placebo"2 tablets".
干预措施: Placebo (Other)
Postoperative
• Group no.2 will receive preoperative sublingual placebo "2 tablets" and postoperative sublingual 400 microgram of misoprostol (Sigma) " 2 tablets" .
干预措施: Misoprostol (Drug)
Postoperative
• Group no.2 will receive preoperative sublingual placebo "2 tablets" and postoperative sublingual 400 microgram of misoprostol (Sigma) " 2 tablets" .
干预措施: Placebo (Other)
结局指标
主要结局
Need for extra uterotonics
时间窗: 24 hours
次要结局
- postpartum hemorrhage(24 hours)
- intraoperative blood loss(intraoperative)
- neonatal outcome(5 minutes)
研究者
Mohamed S Sweed, MD
Assistant Professor
Ain Shams University