Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin in UnijectTM in Mali
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Mean change in hemoglobin
研究概览
简要总结
This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor.
详细描述
This study will assess the programmatic implications (including feasibility, acceptability, costs, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for both drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women delivering at home with a trained study provider who are able to provide informed consent
排除标准
- •women with known contraindications to prostaglandins
研究组 & 干预措施
Misoprostol
600 mcg oral misoprostol administered during the third stage of labor
干预措施: misprostol (Drug)
UnijectTM
10 IU oxytocin delivered IM with UnijectTM during he third stage of labor
干预措施: UnijectTM (Device)
结局指标
主要结局
Mean change in hemoglobin
时间窗: during 3rd trimester and 1-3 days postpartum
To establish the comparable effectiveness of two technologies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb. This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden). The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible.
次要结局
- additional interventions(during birth and 1-3 days postpartum)
- referrals(1-3 days postpartum)
- acceptability(1-3 days postpartum)
- occurrence and management of side effects(1 hour postpartum)
- correct timing of drug administration(collected immediately following birth, verified 1-3 days postpartum)
- change in hemoglobin ≥ 2 g/dL(during third trimester and 1-3 days postpartum)