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临床试验/NCT02562300
NCT02562300已完成2 期

Comparative Study of Sublingual Misoprostol Versus Oxytocin in Reducing Bleeding at Cesarean Section

Assiut University0 个研究点目标入组 120 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
120
主要终点
Blood loss in ML

研究概览

简要总结

Postpartum haemorrhage continues to be a leading cause of maternal morbidity and mortality worldwide and that is according to the estimates of the World Health Organization in 1998. Average blood loss during delivery progressively increases with the type of delivery, vaginal delivery (500 ml), cesarean section (1000 ml) and emergency hysterectomy (3500 ml) of blood.

A reduction of operative blood loss at cesarean section has a great benefit to the patients in terms of decreased postoperative morbidity and a decrease in risks associated with blood transfusions. The routine use of oxytocin is associated with a significant reduction in the occurrence of postpartum hemorrhage.

Excessive blood loss as estimated by a 10% drop in the hematocrit value postdelivery or by need for blood transfusion, occurs in approximately 4% of vaginal deliveries and 6% of cesarean births.

Although many delivery units use oxytocin as the first line agent to prevent uterine atony at cesarean section, it may not be the ideal agent for prevention of postpartum haemorrhage especially in compromised patients with preeclampsia, cardiac disease or prolonged labor. Oxytocin and specifically its preservative chlorobutanol increases the heart rate and has negative inotropic, antiplatelet and antidiuretic effects.

Misoprostol, a prostaglandin E1 analogue, has been shown in many studies to be an effective myometrial stimulant of the pregnant uterus which binds to prostanoid receptors.

Misoprostol administration, either by oral or rectal route, has been shown to be effective in prevention of postpartum haemorrhage and is considered as an effective alternative to other conventional oxytocics especially in developing countries as it is cheap and thermostable.

Pharmacokinetic studies suggested that the bioavailability of misoprostol after sublingual administration was higher than those after oral or vaginal administration.

A few studies are now available for the use of sublingual misoprostol in the prevention of postpartum haemorrhage following vaginal delivery and have reported it as an effective and convenient route of administration.

However, none of the studies conducted so far have evaluated the response of sublingual misoprostol for prevention of postpartum haemorrhage during cesarean section.

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

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

入选标准

  • Gestational age 37-40 wk.
  • Elective lower segment cesarean section.
  • Under spinal anesthesia.

排除标准

  • Anemia (Hb> 8 g%).
  • Multiple gestation.
  • Antepartum hemorrhage.
  • Poly-hydramnios.
  • Two or more previous cesarean sections.
  • History of previous rupture uterus.
  • Current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy.

研究组 & 干预措施

Sublingual misoprostol

Active Comparator

The patients in this arm received 400 micrograms of sublingual misoprostol, immediately after delivery of the neonate.

干预措施: Misoprostol (Drug)

oxytocin

Active Comparator

The patients in this arm received 20 IU oxytocin dissolved in 1 L of Lactated Ringer's or glucose solution) at the rate of 125 ml /h , immediately after delivery of the neonate.

干预措施: Oxytocin (Drug)

结局指标

主要结局

Blood loss in ML

时间窗: 1 year

次要结局

  • Hematocrit value (%)(1 year)

研究者

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

Mohammed Khairy Ali

Dr

Assiut University

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