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临床试验/NCT03967171
NCT03967171已完成不适用

The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery: a Randomised Controlled Trial

Bezmialem Vakif University2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2019年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
2
主要终点
blood loss during elective cesarean section

研究概览

简要总结

This study compares the effect of starting intravenous oxytocin infusion early before uterine incision versus late after umbilical cord clamping on the blood loss during elective cesarean section

详细描述

Postpartum hemorrhage (PPH) is still the major cause of maternal morbidity and mortality worldwide contributing to nearly 25% of direct maternal deaths. The average blood loss during cesarean section is 1000 ml which is nearly double the blood loss during vaginal delivery. Worldwide, the most commonly used uterotonic for the prevention of PPH is oxytocin. Several regimens of oxytocin have been tested during cesarean section with variable wanted (uterotonic) and unwanted (cardiovascular) effects. In the current study, we tested the hypothesis that initiating IV oxytocin infusion earlier before uterine incision would induce a rapid acceptable uterine contraction and minimize the intraoperative blood loss than the same dose administered after delivery of the fetus.

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
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • single fetus at term >37 weeks of gestational age

排除标准

  • history of previous cesarean section
  • history of previous uterine surgery
  • multiple gestation, placenta previa, polyhydramnious, fetal macrosomia
  • women at high risk for uterine atony such as anemia (Hb < 8 gm/dL)
  • uterine atony history
  • gestational diabetes mellitus, gestational hypertension, preeclampsia, current or previous history of heart disease, liver, renal disorders or known coagulopath

研究组 & 干预措施

before uterine incision oxytocin group

Experimental

IV infusion of 20 IU of oxytocin started before uterine incision

干预措施: before uterine incision oxytocin (Other)

after clamping the umbilical cord oxytocin group

Active Comparator

IV infusion of 20 IU of oxytocin started immediately after clamping the umbilical cord

干预措施: after clamping the umbilical cord oxytocin (Other)

结局指标

主要结局

blood loss during elective cesarean section

时间窗: 2 hours

The intraoperative blood loss will be measured by adding the volume of the suction bottle with the blood soaked sponges (know dry weight). The blood loss was estimated after excluded amniotic fluid volume in the suction bottle in each case

次要结局

  • postoperative blood loss(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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