COMPARISON BETWEEN RECTAL & SUBLINGUAL MISOPROSTOL BEFORE CAESARIAN SECTION TO REDUCE INTRA & POST-OPERATIVE BLOOD LOSS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 636
- 试验地点
- 1
- 主要终点
- Intraoperative Blood Loss
研究概览
简要总结
The aim of the work is to evaluate & compare the effectiveness of rectally administered PGE1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before caesarean section to decrease blood loss during and after the operation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients booked for elective cesarean section.
- •Singleton pregnancies. 3- Full term pregnancies (GA 37-42 weeks). 4- Patients with only previous one cesarian section
排除标准
- •Primigravida.
- •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.
- •Contraindication to spinal anesthesia.
- •Previous myomectomy.
- •Previous two or more C.S.
研究组 & 干预措施
sublingual misoprostol & rectal placebo
will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets".
干预措施: Misoprostol (Drug)
rectal & sublingual placebo
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
干预措施: Placebo (Other)
rectal misoprostol & sublingual placebo
will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets".
干预措施: Misoprostol (Drug)
结局指标
主要结局
Intraoperative Blood Loss
时间窗: from start of cesarean section till the end of operation (average one hour)
次要结局
- Incidence of Adverse Effects(24 hours)
- Need for Extra Analgesics(average 24 hours)
- Need for Extra Ecbolics (Oxytocin).(from start of cesarean section till the end of operation (average one hour))
- APGAR Score(1minute and 5 minutes from delivery of the fetus)
- Time to Resume Bowel Habits(average 24 hours)
- Need for Postoperative Blood Transfusion(average 24 hours)
- Incidence of Wound Sepsis(upto one week)
研究者
Mohamed S Sweed, MD
Mohamed S. Sweed, Lecturer of Obstetrics &Gynecology, Ain Shams University
Ain Shams University