Treatment of Postpartum Hemorrhage With Misoprostol: Who do we Treat? Who Will Develop Fever?
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 635
- 试验地点
- 2
- 主要终点
- Rates of high fever (≥40.0°C)
研究概览
简要总结
This study seeks to assess whether populations of women in Latin America outside Quito, Ecuador are at increased risk for developing elevated body temperature above 40.0°C following PPH treatment with 800mcg sublingual misoprostol. The study will be carried out in hospitals representative of different regions of Latin America to explore environmental and genetic hypotheses related to the occurrence of misoprostol-induced fever. Postpartum blood loss, pulse and blood pressure will be systematically measured for all women enrolled to explore new clinical indicators for identifying women who require clinical intervention for excessive bleeding. Blood samples will be collected among women treated with misoprostol to investigate genetic factors responsible for elevated body temperature induced by misoprostol.
The investigators hypothesize that rates of high fever (≥40.0°C) following misoprostol treatment (800mcg given sublingually) will be variable across settings. The investigators expect that the side effect profile following 800 mcg misoprostol given sublingually, in particular the rates of any shivering and fever ≥38.0°C, will be comparable to previous results using misoprostol for PPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able and willing to give informed consent
- •Vaginal delivery
- •Postpartum hemorrhage due to suspected uterine atony
- •Able and willing to give informed consent
排除标准
- •Known allergy to misoprostol or other prostaglandins
- •Underwent a c-section during the current delivery
- •Unable to provide informed consent due to mental impairment, distress during labor or other reason
- •Unwilling and/or unable to respond to brief questionnaires or have her blood drawn
研究组 & 干预措施
PPH Treatment
800mcg sublingual misoprostol
干预措施: Misoprostol (Drug)
结局指标
主要结局
Rates of high fever (≥40.0°C)
时间窗: First 2 hours postpartum
Percentage of women with body temperature measures ≥40°C
次要结局
- Acceptability of regimen and side effects to women(Interviewed prior to hospital discharge (about 24 hours postpartum))
- Genetic factors responsible for elevated body temperature(sample taken 24-48 hours postpartum)
- Side effect profile of misoprostol for PPH treatment(Side effects observed for 3 hours post-treatment with misoprostol for PPH)
- Shock index values(First hour of the puerperium)