A Randomized Controlled Community Study of the Effectiveness of Misoprostol for PPH Treatment at the Community Level (Home Births Attended by Primary Care Unit Staff) in Etay El Barood and Kafr El Dawar Districts (El Beheira Governorate), Egypt
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Change in hemoglobin measurement of >2 g/dL pre- to -post-delivery.
研究概览
简要总结
This randomized controlled community-based trial will assess the effectiveness of administration of 800 mcg sublingual misoprostol with standard of care vs. placebo with standard of care for postpartum hemorrhage treatment at the community level, primarily home births attended by primary health care unit (PHU) staff in Etay El Barood and Kafr El Dawar districts (El Beheira governorate), Egypt. Standard of care per national guidelines in this setting is referral to a higher level health facility.
详细描述
Hospital-based clinical trials have demonstrated misoprostol to be a safe and effective treatment option for postpartum hemorrhage (PPH). Additional research is needed to demonstrate how these findings translate into program effectiveness at lower levels of the health care system, including community home births, where access to skilled providers and treatment options are limited and misoprostol could potentially have the greatest impact on maternal health outcomes. This randomized controlled community treatment trial will assess the effectiveness of misoprostol with standard of care (i.e., referral to higher level care) vs. placebo with standard of care for PPH treatment at the community level, primarily home births attended by primary health care unit staff in Etay El Barood and Kafr El Dawar districts (El Beheira governorate), Egypt. This research will help guide decisions on how to introduce misoprostol into PPH care programs in different contexts such as primary care settings, including community-based home births.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women delivering with provider from participating primary health unit (PHU)
- •willing and able to give informed consent
- •vaginal delivery
排除标准
- •women too advanced into active labor to provide informed consent
- •known allergy to misoprostol and/or other prostaglandin
- •women presenting with pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, antepartum hemorrhage, previous complication in the third trimester (should be referred to higher level care for delivery)
结局指标
主要结局
Change in hemoglobin measurement of >2 g/dL pre- to -post-delivery.
时间窗: Before delivery (at onset of labor), after delivery (2 to 4 days after delivery)
Proportion of women with a change in hemoglobin of \>2 g/dL pre- to post-delivery, as measured by the HemoCue machine at both time points.
次要结局
- Proportion of women transferred to higher level care(Within 2 to 4 days after delivery)
- Proportion of women for whom intervention was correctly administered(Within 1 hour of PPH diagnosis)
- Cost-effectiveness(Within 2 to 4 days after delivery)
- Proportion of women receiving additional interventions to treat PPH(Within 2 to 4 days after delivery)
- Proportion of women with side effects(Within 24 hours of delivery)