Adjuvant Use of Misoprostol and Oxytocin vs. Carbetocin for the Prevention of Post-partum Hemorrhage in Elective Cesarian Section
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- incidence of post-partum hemorrhage
研究概览
简要总结
This prospective randomized double-blind clinical trial will be conducted at Ain-Shams University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100 ug carbetocin intravenous after cord clamping.
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
- •Women with singleton pregnancy Women scheduled for elective CS full term (gestational age ≥37 weeks).
排除标准
- •hypersensitivity to oxytocin, carbetocin or prostaglandins
- •contraindication to prostaglandins (e.g. glaucoma)
- •history of significant heart disease
- •severe asthma
- •history or evidence of liver
- •renal or vascular disease
- •history of coagulopathy
- •thrombocytopenia or anticoagulant therapy
- •women with HELLP syndrome
- •eclampsia
- •women presenting by placental abruption
- •contraindication to spinal anesthesia as carbetocin is licensed for use with regional anesthesia only.
研究组 & 干预措施
Misoprostol + Oxytocin
400 ug sublingual misoprostol + 10 IU Oxytocin IVI
干预措施: Misoprostol (Drug)
Misoprostol + Oxytocin
400 ug sublingual misoprostol + 10 IU Oxytocin IVI
干预措施: Oxytocin (Drug)
Misoprostol + Oxytocin
400 ug sublingual misoprostol + 10 IU Oxytocin IVI
干预措施: Placebo (Drug)
Carbetocin
100 ug Carbetocin IV
干预措施: Carbetocin (Drug)
Carbetocin
100 ug Carbetocin IV
干预措施: Placebo (Drug)
结局指标
主要结局
incidence of post-partum hemorrhage
时间窗: 24 hours
amount of blood loss
时间窗: 24 hours
次要结局
- Number of participants with NICU admission(24 hours)
- Number of participants needing extra uterotonic drug (10 IU oxytocin IVI)(24 hours)
- Number of participants needing hemostatic surgical interventions(intra-operative)
- Hemoglobin deficit in gm/dl(24 hours)
- APGAR score at 1 minute and 5 minutes(1 minute and 5 minutes)
- Drug side effects(24 hours)
- Time till resuming bowel habits(24 hours)
- hematocrit deficit in %(24 hours)
研究者
Mohamed S Sweed, MD
Dr
Ain Shams University