CTRI/2014/03/004491招募中不适用
Efficacy and safety of 400 microgram misoprostol by sublingual route to augment routine management of third stage of labour in high risk women following vaginal delivery.
NRS MEDICAL COLLEGE KOLKATA1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年1月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Blood loss after delivery and incidence of Post partum Haemorrhage
研究概览
简要总结
The present study is a randomized double bind placebo controlled trial evaluating the efficacy and safety of 400 microgram misoprostol in addition to routine mangement of third stage of labour with 10 units of intramuscular oxytocin in women with high risk factors for PPH following vaginal delivery.The primary outcome measures are the postpartum blood loss and incidence of PPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women with one or more of the high risk factors as multiple pregnancy •polyhydramnios •prolonged labour •labor augmented by oxytocin.
- •â€¢H/O PPH in previous pregnancy.
- •â€¢Post caesarean section (for vaginal delivery) •Obese patient (BMJ >30) •Grand multipara •APH •Severe preeclampsia/eclampsia.
- •â€¢Anaemia(hb<10gm%).
排除标准
- •Any contraindications for the use of misoprostol and oxytocin such as known hypersensitivity, asthma, epilepsy etc.
- •Cardiovascular, hepatic, haematological disorders.
- •Temperature >38ï‚°C.
结局指标
主要结局
Blood loss after delivery and incidence of Post partum Haemorrhage
时间窗: From delivery of the newborn to 1 hour after delivery
次要结局
- 1.Post parum drop of Haemoglobin concentration(2. need for additional oxytocic and blood transfusion)
研究者
研究点 (1)
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