Randomized, Double Blind Trial of Magnesium Sulfate Tocolysis Versus Intravenous Saline for Suspected Placental Abruption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours
研究概览
简要总结
To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.
详细描述
We hope to learn if there is a difference in the efficacy of intravenous magnesium sulfate versus intravenous saline infusion in the resolution of vaginal bleeding and contractions in patients with a suspected placental abruption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •vaginal bleeding and contractions consistent with suspected placental abruption between 24 and 34 weeks gestation.
排除标准
- •preterm labor, severe bleeding necessitating immediate delivery, maternal coagulopathy, fetal distress
研究组 & 干预措施
Magnesium Sulfate
Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour
干预措施: Magnesium Sulfate (Drug)
Normal Saline
Normal Saline 4 gram bolus, followed by 2 grams per hour
干预措施: Normal Saline (Other)
结局指标
主要结局
Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours
时间窗: 48 hours after the randomization
The primary outcome was the proportion of women undelivered at 48 hours with resolution of vaginal bleeding and uterine contractions.
次要结局
- Neonatal Apgar Score at 5 Minutes(At 5 minutes after birth)
- Gestational Age at Delivery (Weeks)(Time of delivery)
研究者
Yasser Yehia El-Sayed
Professor of Obstetrics and Gynecology
Stanford University