NCT00906126已完成1 期
Oral Misoprostol for Labor Augmentation: A Dose-Finding Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- uterine hyperstimulation
研究概览
简要总结
A phase I, open-label trial to determine a safe dose of oral misoprostol required to augment labor in nulliparous women diagnosed with arrest of dilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •nulliparous
- •gestational age of at least 36 weeks
- •singleton gestation
- •cephalic presentation
- •reassuring fetal heart rate
- •4 cm or greater cervical dilation
- •ruptured membranes with clear amnionic fluid
- •intrauterine pressure catheter in place
- •less than 200 MVU's
排除标准
- •non-reassuring fetal heart rate
- •meconium-stained amnionic fluid
- •previous uterine incision
- •maternal fever
- •pregnancy-induced hypertension or other pregnancy-related complications
- •known fetal anomalies
- •placenta previa or unexplained vaginal bleeding
- •estimated fetal weight of 4,500 grams or greater
- •evidence of cephalopelvic disproportion
- •any moderate or severe preexisting disease
- •contraindication to the use of prostaglandins
研究组 & 干预措施
Oral Misoprostol 1
Experimental
Oral misoprostol 25 micrograms every 4 hours for up to two doses.
干预措施: Misoprostol (Drug)
Oral Misoprostol 2
Experimental
Oral misoprostol 50 micrograms every 4 hours for up to two doses.
干预措施: Misoprostol (Drug)
Oral Misoprostol 3
Experimental
Oral misoprostol 100 micrograms every 4 hours for up to two doses.
干预措施: Misoprostol (Drug)
Oral Misoprostol 4
Experimental
Oral Misoprostol 50 micrograms every 2 hours for up to two doses.
干预措施: Misoprostol (Drug)
Oral Misoprostol 5
Experimental
Oral Misoprostol 75 micrograms every 4 hours for up to two doses.
干预措施: Misoprostol (Drug)
结局指标
主要结局
uterine hyperstimulation
次要结局
- need for oxytocin augmentation
- adequate uterine activity
- time from administration of study drug to delivery
- route of delivery and indications
- maternal and neonatal infectious morbidity
- neonatal outcomes
研究者
研究点 (1)
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