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临床试验/NCT04518176
NCT04518176Unknown不适用

Clinical Outcomes of Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins: A Randomized Controlled Trial

Aswan University Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年9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
发起方
入组人数
400
试验地点
1
主要终点
mean Blood loss after placental separation

研究概览

简要总结

Objective to assess the effectiveness of prophylactic bilateral uterine artery ligation (BUAL) in reducing the incidence of postpartum hemorrhage during cesarean delivery among women with twin pregnancy

详细描述

A randomized clinical trial at Aswan University Maternity Hospital, Egypt. Women with twin pregnancy undergoing scheduled or emergency cesarean were randomized into two groups. In the BUAL group, women underwent BUAL before placental delivery; in the control group, women had cesarean delivery without BUAL. The primary outcome was the estimated blood loss during a cesarean

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

盲法说明

open label randomized controlled study

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women undergoing cesarean section
  • twin pregnancy

排除标准

  • Placenta previa.
  • Ante-partum hemorrhage.
  • patient refuse to participate

研究组 & 干预措施

study group

Experimental

patients with twin pregnancy undergoing cesarean section underwent bilateral uterine artery ligation and received oxytocin.

干预措施: bilateral uterine artery ligation (Procedure)

study group

Experimental

patients with twin pregnancy undergoing cesarean section underwent bilateral uterine artery ligation and received oxytocin.

干预措施: Oxytocin (Drug)

control group

Active Comparator

patients with twin pregnancy undergoing cesarean section received oxytocin only.

干预措施: Oxytocin (Drug)

结局指标

主要结局

mean Blood loss after placental separation

时间窗: 30 minutes

by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set

次要结局

  • Number of Participants with postpartum hemorrhage(12 hours)
  • The number of participant needed for blood transfusion(24 hours)

研究者

发起方
Aswan University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

hany farouk

A Professor

Aswan University Hospital

研究点 (1)

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