Misoprostol in the Treatment of Post Partum Hemorrhage: A Placebo Randomised Controlled Trial in 4 Karachi Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Blood loss greater than or equal to 500 mls after enrolment
研究概览
简要总结
Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women delivering vaginally with clinically diagnosed PPH requiring uterotonics
排除标准
- •Refusal to give consent for participation or if the woman is too distressed to give consent
- •Woman is not entitled to give informed consent (e.g. minors without a guardian)
- •Woman who had a caesarean section
- •Delivery is regarded as abortion (gestational age < 28 weeks)
研究组 & 干预措施
Misoprostol
three tablets of active misoprostol (600 mcg) given sublingually
干预措施: Misoprostol (Drug)
Placebo
three tablets resembling misoprostol given sublingually
干预措施: Misoprostol (Drug)
结局指标
主要结局
Blood loss greater than or equal to 500 mls after enrolment
时间窗: Blood loss measured for minimum of 1 hour or until active bleeding ceased
次要结局
- Side effects(observed or reported following study treatment and prior to discharge)
- Average blood loss(Blood loss measured for minimum of one hour or until active bleeding ceased)
- Clinical complications (need for transfusion, hysterectomy)(After delivery and prior to hospital discharge)
- Pre-delivery and post-delivery hemoglobin measures(Pre-delivery hemoglobin measured upon admission to hospital (during labor) and measured postpartum 12-24 hours after delivery)