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临床试验/NCT02306733
NCT02306733Unknown3 期

Ergometrine Versus Oxytocin in the Management of Atonic Post-partum Haemorrhage (PPH) in Women Delivered Vaginally: A Randomised Controlled Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
200
试验地点
2
主要终点
Need for other uterotonics

研究概览

简要总结

200 women with PPH will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) and group 2 will receive oxytocin 10 IU (Syntocinon®, Novartis, Switzerland). The investigators will not include a control group for ethical reasons.

详细描述

Obstetric haemorrhage remains one of the major causes of maternal death in both developed and developing countries. Postpartum haemorrhage (PPH) is defined as a blood loss >500 ml more of blood from the genital tract within 24 hours of the birth of a baby. PPH can be minor (500-1000 ml) or major (more than 1000 ml). The most frequent cause of PPH is uterine atony, contributing up to 80 % of the PPH cases.

Risk factors of atonic PPH include multiple pregnancy, placenta previa, previous PPH, body mass index (BMI) >30, prolonged labour, fetal macrosomia>4kg and primipara> 40 years.

Oxytocin is currently the uterotonic of first choice. It has proven to decrease the incidence of PPH by 40 % and has a rapid onset of action and a good safety profile. A disadvantage of oxytocin is its short half-life of 4-10 min, regularly requiring a continuous intravenous infusion or repeated intramuscular injections. Despite decades of empirical use in clinical practice, there are no trials comparing ergometrine and oxytocin as first-line agents for the treatment (rather than prevention) of PPH.

The study will be conducted in Cairo university hospitals and BeniSuef university hospitals. All patients attending the labour ward will be invited to participate in the study, the invitation will include a clear full explanation of the study. Only patients signing informed written consents will participate in the study.

200 women with PPH will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) and group 2 will receive oxytocin 10 IU (Syntocinon®, Novartis, Switzerland). The investigators will not include a control group for ethical reasons.

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
Double (Participant, Investigator)

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

  • Atonic PPH

排除标准

  • Gestational age<37 weeks
  • Hypertension, cardiac disease or preeclampsia

研究组 & 干预措施

Ergometrine

Active Comparator

100 women with atonic PPH will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) slowly intravenous (iv)

干预措施: Ergometrine (Drug)

Oxytocin

Active Comparator

100 women with atonic PPH will receive oxytocin 10 IU (Syntocinon® Novartis, Switzerland) slowly intravenous.

干预措施: Oxytocin (Drug)

结局指标

主要结局

Need for other uterotonics

时间窗: 2 minutes after giving the drug

The uterus will be palpated to check the uterine tone and the amount of the bleeding will be estimated 2 minutes after giving the drug. Bleeding will be estimated by weighing the swaps and using pictorial charts.

次要结局

  • Development of major PPH(10 minutes after giving the drug.)

研究者

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

AbdelGany Hassan

Lecturer of Gynecology and Obstetrics

Cairo University

研究点 (2)

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