Comparison Between Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- amount of blood loss
研究概览
简要总结
Double blinded randomized controlled study
详细描述
Women will be randomized into two groups using COMPUTER-GENERATED RANDOM NUMBER LIST.
264 dark colored envelops will be serially numbered containing the corresponding letter of the corresponding drug that will be used.
Group C: 132 women in the carbetocin group will receive a bolus of 100 μg intravenous injection at delivery of the anterior shoulder.
Group O: 132 women in the oxytocin group will receive 5 IU of oxytocin by slow intravenous injection at delivery of the anterior shoulder.
- All patients will receive general anaesthesia.
- Operation will be carried out by a three year registrar (at least).
- Uterus will be repaired in situ. Primary endpoint: is the amount of blood loss.
- Blood loss will be estimated using the change in Hb% and hematocrit, the actual blood loss will be calculated using the following equation:
- The actual blood loss equals the estimated blood volume X difference between the initial hematocrit and the final hematocrit / the initial hematocrit
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Multiple pregnancy
- •Presence of uterine fibroid
- •Previous Myomectomy
- •Presence of placenta previa
- •Past History of PPH
- •Fetal Macrosomia
- •Polyhydramnios
排除标准
- •Hypertension
- •Preeclampsia
- •Cardiac, Renal, Liver diseases
- •History of hypersensitivity to Carbetocin
研究组 & 干预措施
Carbetocin arm
100 μg intravenous injection at delivery of the anterior shoulder
干预措施: Carbetocin (Drug)
oxytocin arm
5 IU intravenous injection at delivery of the anterior shoulder
干预措施: Oxytocin (Drug)
结局指标
主要结局
amount of blood loss
时间窗: 24 hours
次要结局
- need for another uterotonic medication(5 minutes)
- need for blood transfusion or operative intervention(during surgery)
研究者
Maged El.Sherif
Registrar of OB/GYN
Ghamra Military Hospital