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临床试验/NCT04756661
NCT04756661已完成不适用

Carbetocin Versus Combined Oxytocin and Misoprostol for Prevention of Postpartum Hemorrhage in Women With Severe Preeclampsia

Assiut University1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
1
主要终点
The rate of postpartum hemorrhage more than 1000 ml

研究概览

简要总结

The study compares the effect of Intravenous carbetocin versus combined use of intravenous oxytocin and rectal misoprostol for prevention of postpartum hemorrhage during delivery of women with severe preeclampsia

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
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant women which diagnosed with severe pre-eclampsia.
  • Singleton pregnancy.
  • Termination of pregnancy by Cesarean section after 28 weeks of gestation.

排除标准

  • Suspected or proven placental abruption.
  • Known placenta Previa or acreata.
  • Multiple pregnancies.
  • Obesity (BMI >35).
  • Anemia (<9 g/dl).
  • Retained placental tissues.
  • Big baby (> 4 kg).
  • Presence of coagulopathy.
  • Polyhydramnios.
  • Presence of Uterine fibroids.
  • Medical diseases as; cardiac, liver, renal or endocrine diseases.
  • General anesthesia.

研究组 & 干预措施

Oxytocin plus misoprostol

Active Comparator

Patient received 10 units of oxytocin IV drip and 400 mcg of misoprostol rectally after anesthesia.

干预措施: Misoprostol (Drug)

Carbetocin

Experimental

Patient received 100 mcg of carbetocin intravenous over one minute immediately after delivery of the baby.

干预措施: Carbetocin (Drug)

Oxytocin plus misoprostol

Active Comparator

Patient received 10 units of oxytocin IV drip and 400 mcg of misoprostol rectally after anesthesia.

干预措施: Oxytocin (Drug)

结局指标

主要结局

The rate of postpartum hemorrhage more than 1000 ml

时间窗: 30 minutes

the amount of bleeding during and after CS

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Abbas

Principal investigator

Assiut University

研究点 (1)

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