NCT00906347已完成4 期
A Randomized, Controlled Trial of Oral Misoprostol for Labor Augmentation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Uterine Tachysystole
研究概览
简要总结
This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Clinical decision to augment labor
- •Gestational age > than or equal to 36 weeks
- •Singleton gestation
- •Cephalic presentation
- •Reassuring fetal heart rate tracing
- •Cervical dilation between 4 and 8 cm
- •Ruptured membranes with clear amniotic fluid
- •Intrauterine pressure catheter in place
- •Less than 200 MVUs in a 10 minute period
- •5 or fewer contractions in a 10 minute period
- •English or Spanish speaking patient
排除标准
- •Non-reassuring fetal heart rate tracing at time of enrollment
- •Meconium stained amniotic fluid
- •Previous uterine incision
- •Maternal fever (defined as greater than 37.9 C)
- •Known fetal anomalies
- •Placenta previa or unexplained vaginal bleeding
- •Estimated fetal weight of 4,500 grams or more
- •Abnormal maternal bony pelvis
- •Grandmultiparity
研究组 & 干预措施
Oxytocin augmentation
Active Comparator
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
干预措施: Oxytocin (Drug)
Misoprostol augmentation
Active Comparator
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Uterine Tachysystole
时间窗: Up to four hours after administration of study drug
Defined as six contractions in two consecutive 10-minute periods
次要结局
- Infant Apgar Score <4(5 minutes after delivery)
- Umbilical Cord Artery pH <7.1(Obtained at delivery)
- Admission of Neonatal Intensive Care Unit(Until hospital discharge)
- Maternal Chorioamnionitis(During labor)
- Maternal Hypovolemia Requiring Blood Transfusion(Until hospital discharge)
- Method of Delivery(At delivery)
- Time Elapsed From Start of Labor Augmentation to Delivery(Initiation of augmentation until delivery)
研究者
研究点 (1)
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