Comparative Study on Effects of Sublingual Misoprostol in Addition to Standard Active Management of Third Stage of Labour in Low Risk Parturients in Lagos State University Teaching Hospital, Ikeja.
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 660
- 主要终点
- mean blood loss
研究概览
简要总结
Postpartum haemorrhage is the leading cause of maternal haemorrhage globally. With active management of labour 3 to 16.5% of parturients still experience postpartum haemorrhage. Hence the need for an effective oxytocic in third stage of labour.
详细描述
This is a prospective randomized doubleblind controlled trial involving 660 consenting pregnant women. Eligible subjects will be ransomised into 2 groups of 330 participants. All patients will receive the standard oxytocin 10 units as part of the active management of third stage of labour. However, the study group will be administered sublingual 400 misoprostol while the control group will receive 2tablets of placebo (vitamin c). Measured mean blood loss will be comparee in the 2 groups using statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton in longitudinal lie and cephalic presentation
排除标准
- •refusal of consents, multiple gestation
研究组 & 干预措施
control
Intramuscular oxytocin 10 units, 2 tablets of placebo which will be vitamin c
干预措施: vitamin c (Drug)
study
Intramuscular oxytocin 10 units, 400 micrograms of misoprostol
干预措施: Misoprostol (Drug)
结局指标
主要结局
mean blood loss
时间窗: 1 hour of delivery
次要结局
- number of participants with untowards effects(1 hour of delivery)
研究者
Oyedeko Muyideen Oladipo
Doctor
Lagos State University