NCT02221830已完成早期 1 期
Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Evaluation of Postpartum hematocrit
研究概览
简要总结
Evaluation of the efficacy of postpartum 24 hour oxytocin infusion to reduce blood loss in patients with pre-eclampsia (PE)
详细描述
The overall goal of this study is to evaluate the efficacy of postpartum 24 hour oxytocin infusion as a prevention-oriented strategy to reduce blood loss in patients with pre-eclampsia (PE) in a blinded, placebo controlled, randomized controlled trial.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 13 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •vaginal or cesarean delivery at a gestational age greater than or equal to 20 weeks gestational age;
- •diagnosis of preeclampsia (PE defined using standard definitions based on the ACOG bulletin and the NIH Working Group on High Blood Pressure in Pregnancy (i.e., a systolic blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm Hg on at least 2 occasions at least 6 hours apart after 20 weeks gestation and proteinuria of > 300mg per 24 hour period or > 1+ on dipstick).
- •patients treated with magnesium sulfate for 24 hours post partum at 2g/hr (standard of care when deemed appropriate by clinician for seizure prophylaxis)
排除标准
- •abnormal placentation (previa, accreta, etc)
- •antenatal hemorrhage
- •contraindication to oxytocin
研究组 & 干预措施
Placebo
Placebo Comparator
Normal Saline (standard of care)
干预措施: Placebo (Drug)
Treatment
Experimental
normal saline + oxytocin
干预措施: Oxytocin (Drug)
结局指标
主要结局
Evaluation of Postpartum hematocrit
时间窗: 24 hours postpartum
Postpartum hematocrit (collected 24 hours after delivery unless patient receives blood transfusion, then pre-transfusion hematocrit will be used)
次要结局
- Primary postpartum hemorrhage(Before discharge from hospital)
- Estimated blood loss at delivery(Before discharge from hospital)
- Postpartum blood loss(24 hours postpartum)
研究者
研究点 (1)
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