Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,140
- 试验地点
- 1
- 主要终点
- Estimated Blood loss
研究概览
简要总结
Null hypothesis: 10 IU Oxytocin is better than sublingual misoprostol 600µg in management of third stage of labor Alternative hypothesis: Sublingual misoprostol 600µg is non- inferior to 10 IU oxytocin and will not be more than 6% worse [than 10 IU oxytocin] in management of third stage of labor
详细描述
Background: In Sub- Saharan Africa, one in 35 women die in child birth, 1000 times higher than the western world and Post-Partum Hemorrhage (PPH) accounts for the biggest percentage of maternal morbidity and mortality (WHO, 2005; WHO, 2010). Maternal Mortality in Uganda is one of the highest in the world at 435 for every 100,000 and 25% of these are due to PPH happening within 24 hours after delivery. Oxytocin, the standard of care in PPH management has registered challenges like requirement of sterile injections, requirement of trained personnel, special supply chain/storage conditions like refrigeration and protection from light affecting maximum treatment outcomes especially in poorly resourced developing countries where these are not realized. It has been argued that any effort or developments based on physiological processes towards the reduction of this horrific PPH rate would greatly have a significant impact on the lives of families and women worldwide. Several scholars have thus stressed a vital need to develop simple, practical and inexpensive techniques relevant to prevent and treat PPH in developing countries.
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
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Term mothers [38-41 WOA] above 18 years of age admitted at Mbarara Hospital, Uganda in active labor; anticipating vaginal delivery -
排除标准
- •Complicated labor:
- •confirmed intra-uterine fetal death
- •self-reported maternal heart disease
- •current diagnosis of severe malaria or acute bacterial infection,
- •multiple pregnancy,
- •induced or augmented labor,
- •elective Caesarean section,
- •ante-partum hemorrhage,
- •reported hypersensitivity to prostaglandins
- •altered cognitive status (ACS) as assessed by the MRAs. -
研究组 & 干预措施
Arm A: sublingual misoprostol 600µg
Misoprostol is a uteretonic drug
干预措施: Misoprostol (Drug)
结局指标
主要结局
Estimated Blood loss
时间窗: 24 hours
Estimated blood loss of more than or equal to 500ml
次要结局
- 1) maternal death, 2) pre and post delivery hemoglobin changes 3) pre and post delivery hematocrit changes 4) >10% hemoglobin drop 5) mean postpartum hemoglobin and hematocrit, 6) mean measured blood loss(24 hours)
- 7) placental retention 8) requirement for blood transfusion 9) requirement for additional therapeutic procedures or uterotonics 10) duration of the third stage of labor(24 hours)
- Blood loss of more than 1000ml(24 hours)