Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Haemoglobin concentration (Hb) of greater than or equal to 2 g/dl from pre- to post-delivery
研究概览
简要总结
A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan.
详细描述
A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan. The purpose of the study is to assess the overall clinical and programmatic effectiveness of Traditional Birth Attendants (TBAs) administering 800 mcg sublingual misoprostol to treat Postpartum Haemorrhage (PPH) at the community level.
The study will recruit pregnant women who deliver at home. All women enrolled in the study will receive misoprostol for prevention (600 mcg oral dose). Women diagnosed with PPH will be randomized to receive either a) standard care + 800 mcg sublingual misoprostol (four 200 mcg tablets) or b) standard care + four placebo tablets resembling misoprostol. In this setting, standard care is uterine massage and/or compression and referral to the nearest health facility or attendance by the Lady Health Visitor/ Community Health Nurse.
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 who deliver at home with a study TBA present.
- •Women must be willing and able to provide informed consent
- •Women must agree to participate in a follow up interview
- •Women must agree to have pre and post-partum haemoglobin taken
排除标准
- •If the woman does not meet any of the above outlined inclusion criteria
研究组 & 干预措施
Misoprostol
women who experience a PPH will be randomized to receive 800 misoprostol (four tablets of 200 mcg administered sublingually)
干预措施: Misoprostol (Drug)
placebo
women who experience a PPH will be randomized to receive 4 placebo tablets administered sublingually
干预措施: placebo (Other)
结局指标
主要结局
Haemoglobin concentration (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.
次要结局
- number of women who found misoprostol treatment to be acceptable(immediately after delivery; 3-5 days post delivery)
- Number of participants who experience side effects(immediately after delivery; 3-5 days post delivery)
- number of participants who received additional interventions(immediately after delivery; 3-5 days post delivery)
- number of participants who experience severe adverse events(immediately after delivery; 3-5 days post delivery)