跳至主要内容
临床试验/NCT00107874
NCT00107874已完成2 期

Oral Misoprostol as a Second-line Alternative to Intravenous Oxytocin in Preventing Postoperative Blood Loss After Non-scheduled Cesarean Section: a Randomized, Double-blind, Placebo-controlled Trial

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 1999年1月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
56
试验地点
2
主要终点
Reduction of postpartum hemorrhage

研究概览

简要总结

Postpartum hemorrhage (PPH) ranks among the leading causes of maternal morbidity and mortality, both in developed and developing countries.

With this trial, we sought to determine the effectiveness of oral misoprostol as an uterotonic drug in comparison with intravenous oxytocin, in patients with a low risk of PPH undergoing non-scheduled Cesarean section.

We therefore compared the intra- and postoperative blood loss, as well as drug related side effects in patients, treated by the same surgical and anesthesiological team in one institution.

详细描述

Postpartum hemorrhage (PPH) is still among the leading causes of maternal morbidity and mortality. The incidence of PPH is reduced by active management of the third stage of labor which includes the use of uterotonics for pharmacological prophylaxis. However, there is an on-going debate about the optimal drug selection since uterotonics such as oxytocin and methylergometrine are liable for specific side effects and complications when administered within a dose range needed to be effective for PPH. In the search for an alternative to these conventional standard uterotonics, misoprostol (prostaglandin E1) has turned out to be an effective therapeutic option and has been implemented in actual treatment regimens. The objective of this study was to compare the effectiveness of oral applicated misoprostol versus intravenous oxytocin in reducing blood loss in low risk obstetric patients undergoing non-scheduled cesarean section (CS) under spinal anesthesia.

Comparison:

In this prospective, double blind study, parturients undergoing CS were randomized to receive either a) oral misoprostol and an infusion of normal saline supplemented with placebo, or b) an oral placebo and an infusion of normal saline, supplemented with oxytocin subsequently to intravenous oxytocin after cord clamping in both groups.

The primary outcomes were the amount of intra- and postoperative blood loss and the occurrence of drug-related side effects.

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
Double

入排标准

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

入选标准

  • Non-scheduled primary or secondary Cesarean section (CS) after the 37th week of gestation

排除标准

  • Emergency CS
  • Fetal distress
  • Fetal malformations
  • Preeclampsia and HELLP (Hemolysis-Elevated Liver enzymes-Low Platelet count syndrome)
  • Hypersensitivity to prostaglandins
  • Coagulopathy
  • Severe systemic disorders
  • An American Society of Anesthesiologists (ASA) physical status >/= 3
  • Severe asthma
  • Prior myomectomy
  • Maternal fever (> 38.5 °C)

结局指标

主要结局

Reduction of postpartum hemorrhage

次要结局

  • Blood loss
  • medicamentous side effects
  • efficacy of medicaments

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验