CARBETOCIN VERSUS RECTAL MISOPROSTOL FOR MANAGEMENT OF THIRD STAGE OF LABOR IN WOMEN AT LOW RISK OF POSTPARTUM HEMORRHAGE
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- prevention of post partum hemorrhage after vaginal delivery
研究概览
简要总结
150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®, Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood samples were tested to measure hemoglobin levels upon admission to the labor room and 12 hours after delivery
详细描述
150 pregnant women admitted for spontaneous, induced or augmented vaginal delivery and categorized as low risk for postpartum hemorrhage (PPH) were divided randomly into two groups. Carbetocin group (C) received 1 ampoule of Carbetocin (100 μg/ml) (Pabal®, Draxis/Multipharma, Egypt, under license from DRAXIS PHARMA-Canada) added to 10 cc saline and given IV after the delivery of the baby. Misoprostol group (M) received 2 rectal misoprostol tablets (800 μg) (Misotac; SIGMA Pharm, Cairo, Egypt) after the delivery of the baby. Blood samples were tested to measure hemoglobin levels upon admission to the labor room and 12 hours after delivery
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •singleton pregnancy 36-40 weeks of gestation vertex presentation. normotensive hemoglobinlevel > 10 gm/dl
- •Noncomplicated pregnancy
排除标准
- •Women with history of Postpartum hemorrhage in previous deliveries uterine fibroids previous cesarean section medical disorders (e.g. diabetes, anemia, coagulation disorders, cardiac, hepatic and renal diseases) antepartum hemorrhage
研究组 & 干预措施
CARBETOCIN
received 1 ampoule of Carbetocin (100 μg/ml) added to 10 cc saline and given IV after the delivery of the baby.
干预措施: Carbetocin (Drug)
MISOPROSTOL
received 4 rectal misoprostol tablets (800 μg) after the delivery of the baby.
干预措施: Misoprostol (Drug)
结局指标
主要结局
prevention of post partum hemorrhage after vaginal delivery
时间窗: 24 hours after delivery
Number of participants experienced postpartum hemorrhage
次要结局
- drugs side effects(24 hours after delivery)
研究者
Ahmed M Maged, MD
professor
Cairo University