Assessment of Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of fever above 40.0 degrees centigrade
研究概览
简要总结
This study will evaluate side effects after sublingual misoprostol (600 mcg) as a first-line treatment for primary postpartum hemorrhage (PPH) due to suspected uterine atony.
详细描述
The study purpose is to confirm whether a lower, 600 mcg dose of sublingual misoprostol will reduce the incidence of elevated body temperature (≥40°C) associated with misoprostol. The study will compare the incidence of high fevers following treatment with 600 mcg sublingual misoprostol to previously documented rates using 800 mcg sublingual misoprostol. An additional line of research is to investigate whether some women are more susceptible to experiencing high fevers following misoprostol administration, and whether genetic factors are responsible for misoprostol-induced fevers.
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
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 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
- •Oxytocin given during 3rd stage of labor
排除标准
- •Known allergy to prostaglandins or misoprostol
- •Underwent cesarean section
- •Postpartum hemorrhage NOT due to suspected uterine atony
- •Oxytocin NOT given during 3rd stage of labor
- •Severe ill health
- •Unable to give informed consent
研究组 & 干预措施
600 mcg of sublingual misoprostol
干预措施: Misoprostol (Drug)
结局指标
主要结局
Rate of fever above 40.0 degrees centigrade
时间窗: Body temperature measured at 60 minutes and 90 minutes post-treatment with misoprostol for PPH
% of women with body temperature measures ≥40°C
次要结局
- Side effect profile of misoprostol for PPH treatment(Side effects observed for 3 hours post-treatment with misoprostol for PPH)
- Acceptability of side effect profile among women(Women interviewed prior to hospital discharge about acceptability of side effects (24 hours postpartum))