Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Post-partum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- The amount of blood loss
研究概览
简要总结
The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery.
详细描述
The first cause of hemorrhage at the time of delivery is uterine atony; therefore, there is general agreement that active management of the third stage of labor is recommended.
Oxytocin is the most widely used uterotonic agent but has a half-life of only 4-10 min, that is why it is better administered as a continuous intravenous infusion to achieve sustained uterotonic activity. Carbetocin is a synthetic long-acting oxytocin agonistic analog with prolonged half-life prolonging its pharmacological effects. Its prolonged uterine activity may theoretically offer advantages over oxytocin in the management of the third stage of labor. The side-effect profile of carbetocin was not found to be different from that of Oxytocin but may prove to be advantageous when compared to Syntometrine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study will be a prospective double-blind randomized study
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
- •All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation
排除标准
- •gestational age<37 weeks,
- •genital tract trauma,
- •coagulation defect,
- •women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
- •known hypersensitivity to carbetocin or oxytocin.
研究组 & 干预措施
oxytocin
The patient will be received oxytocin 20 IU by intravenous infusion
干预措施: oxytocin (Drug)
oxytocin plus misoprostol
The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mc sublingual misoprostol
干预措施: oxytocin (Drug)
oxytocin plus misoprostol
The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mc sublingual misoprostol
干预措施: oxytocin plus misoprostol (Drug)
Carbetocin
The patient will be received Carbetocin 100 mic gm IV
干预措施: Carbetocin (Drug)
结局指标
主要结局
The amount of blood loss
时间窗: 6 hours post delivery
calculation of the amount of blood loss by weighing the swabs and using pictorial charts
次要结局
- The number of patients develop blood loss more than 1000 ml(24 hours post delivery)
- The number of patient need blood transfusion(24 hours post delivery)
研究者
hany farouk
Principal Investigator
Aswan University Hospital