Misoprostol for the Treatment of Postpartum Haemorrhage (PPH) Following Self- Administration of Misoprostol Prophylaxis in Home Deliveries.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Hb of greater than or equal to 2 g/dl from pre- to post-delivery
研究概览
简要总结
Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a low cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH), especially in settings where injectable uterotonics are not yet available or feasible to use.
A double-blinded individual randomized controlled study of misoprostol versus placebo in home deliveries in four districts in the Badakshan Province in Afghanistan. The study will recruit pregnant women who are likely to deliver at home. All women enrolled in the study will receive 600 mcg misoprostol to be self-administered as prophylaxis for PPH after delivery of their baby (ies) and before delivery of the placenta.
Women who experience a PPH will be randomized to receive either: a) standard of care + 800 mcg misoprostol (four 200 mcg tablets) or b) standard of care + four placebo tablets resembling misoprostol. In this setting, standard of care is referral.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women must be pregnant
- •Must be able to provide informed consent
- •Must agree to have a community health worker present at the time of delivery
- •Must agree to participate in a follow up interview by the study midwife
- •Must agree to have pre and postpartum haemoglobin taken
排除标准
- •Women who do not meet the inclusion criteria
研究组 & 干预措施
misoprostol
800mcg misoprostol (four tablets of 200 mcg administered sublingually)
干预措施: Misoprostol (Drug)
placebo
4 placebo tablets (resembling misoprostol) administered sublingually
干预措施: placebo (Other)
结局指标
主要结局
Hb of greater than or equal to 2 g/dl from pre- to post-delivery
时间窗: 3-5 days after delivery
The primary outcome will measure the proportion of women who experience a drop in their haemoglobin concentration (Hb) of greater than 2 g/dl from pre- to post-delivery. The outcome will be compared between the two treatment groups.
次要结局
- Side effects(immediately after delivery; 3-5 days post delivery)
- Acceptability(immediately after delivery; 3-5 days post delivery)
- additional interventions(immediately after delivery; 3-5 days post delivery)