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临床试验/NCT03680339
NCT03680339已完成4 期

The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS

Cairo University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年9月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
200
试验地点
1
主要终点
postpartum hemorrhage

研究概览

简要总结

• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Then we will compare between two groups regarding

  • Intaoperative blood loss
  • Risk of Postpartum hemorraghe in the first 24 hrs
  • HB pre and postoperative for all patients

Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit

详细描述

• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Then we will compare between two groups regarding

  • Intaoperative blood loss
  • Risk of Postpartum hemorraghe in the first 24 hrs
  • HB pre and postoperative for all patients

Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women attending for elective CS.
  • Age between 20-35 years.
  • Normal placental site
  • Normal coagulation profile
  • Full term pregnancies(above 37 wks)
  • Medically free
  • Spinal anesthesia
  • Living baby
  • Average liquor by U/S

排除标准

  • • Women attending for emergency CS
  • .age below 20 or above 35
  • Abnormal placentation (Placenta previa,accrete,increta or percreta)
  • Women with coagulopathy
  • Preterm pregnancies (before 37 wks)
  • Medical disorder (Hypertension,Diabetes, Endocrinal disorder)
  • General anathesia
  • Oligo or polyhydraminos by U/S

研究组 & 干预措施

Routine ecbolic group

Active Comparator

100 patients will receive routine ecbolics ( oxytocin) after delivery of baby

干预措施: cesarean section (Procedure)

Routine ecbolic group

Active Comparator

100 patients will receive routine ecbolics ( oxytocin) after delivery of baby

干预措施: Oxytocin (Drug)

Misoprostol group

Active Comparator

The 100 patients will receive routine ecbolics (oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

干预措施: cesarean section (Procedure)

Misoprostol group

Active Comparator

The 100 patients will receive routine ecbolics (oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

干预措施: Misoprostol (Drug)

Misoprostol group

Active Comparator

The 100 patients will receive routine ecbolics (oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

干预措施: Oxytocin (Drug)

结局指标

主要结局

postpartum hemorrhage

时间窗: 24 hours after cesarean section

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 M Maged, MD

professor

Cairo University

研究点 (1)

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