Comparative Effectiveness of Routine Early Versus Delayed Amniotomy for Pregnancies Less Than 37 Weeks Gestational Age: A Randomized Open Label Trial (CEREAL)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Total duration of labor.
研究概览
简要总结
To compare the duration of preterm induction of labor in women undergoing early vs. late or no artificial rupture of membranes (AROM). Maternal and neonatal outcomes will also be compared between the two groups.
详细描述
Women presenting with a preterm singleton pregnancy between 28.0 and 36.6 weeks of gestation with cephalic lie and a medical indication for induction of labor will be approached for this study. The patient/provider must be attempting induction with the goal of vaginal delivery. Women with ruptured membranes, suspected intrauterine infection, prior uterine scar, fetal demise, or a fetal anomaly will be excluded. Women that agree to the study will be randomized to 2 groups: the "early amniotomy" group and the "late amniotomy" group.
Women in the early amniotomy group will undergo artificial rupture of membranes (AROM) prior to reaching cervical dilation of 4 cm. Women in the late amniotomy group may not undergo AROM until they reach cervical dilation of greater than 4 cm or they have been on an oxytocin drip for greater than 10 hours with no cervical change. It is possible that a woman in the late amniotomy group will not undergo AROM at all.
The primary outcome under consideration is time in labor. Secondary outcomes include rates of chorioamnionitis, postpartum endometritis, mode of delivery, and neonatal outcomes.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Preterm singleton pregnancy between 28.0 and 36.6 completed weeks of gestation
- •Fetus in the cephalic position
- •Intent to induce labor for vaginal delivery
- •If cervical ripening is planned, patient must be enrolled within an hour of initiation of ripening. If no ripening is planned, enrollment must be complete prior to starting induction.
排除标准
- •Preterm premature rupture of membranes (PPROM)
- •Fever or suspected chorioamnionitis prior to start of IOL
- •Prior uterine scar
- •Infection with HIV/Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV) or an active Herpes Simplex Virus (HSV) infection
- •Intrauterine fetal demise
- •Major fetal anomaly
- •Cervical dilation > 4 cm
结局指标
主要结局
Total duration of labor.
时间窗: Induction of labor until delivery (1 hr - 48 hrs)
The duration of labor begins with administration of the first induction agent (i.e. Cook balloon, Foley catheter, prostaglandins, or oxytocin) and ends with delivery.
次要结局
- Labor Outcomes:Time from completion of cervical ripening to delivery(Induction of labor until delivery (1 hr - 48 hrs))
- Labor Outcomes: Delivery before 24 hours from start of Induction of Labor (IOL)(Induction of labor until delivery (1 hr - 48 hrs))
- Maternal/Labor Outcomes:Operative vaginal delivery(at delivery)
- Use of amnioinfusion(during labor)
- Recurrent variable or late decelerations(during labor)
- Tachysystole(during labor)
- Use of intrapartum tocolytics(during labor)
- Maternal/Labor Outcomes: Indication for Cesarean delivery(at delivery)
- Maternal intrapartum fever or chorioamnionitis(during labor to delivery)
- Epidural anesthesia(during labor)
- Labor Outcomes: Duration of the 2nd stage of labor(Induction of labor until delivery (1 hr - 48 hrs))
- Maternal Outcome:Cesarean delivery(at delivery)
- Post-partum endometritis:(up to 10 days)
- Meconium stained amniotic fluid(during labor and delivery)
研究者
Clifton O'Neill Brock
Clinical Fellow OBGYN
The University of Texas Health Science Center, Houston