Optimizing Management of the 2nd Stage of Labor: Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2,414
- 试验地点
- 6
- 主要终点
- Spontaneous vaginal delivery
研究概览
简要总结
The investigators propose a large, multicenter, randomized clinical trial of immediate versus delayed pushing for nulliparous women in labor at term reaching complete cervical dilation. The central hypothesis is that immediate pushing in the second stage of labor increases spontaneous vaginal delivery, shortens duration of the second stage, and reduces adverse neonatal and maternal outcomes in nulliparous women. They will pursue the following specific aims: 1) Assess the effectiveness of immediate pushing at complete cervical dilation on the rate of spontaneous vaginal delivery in nulliparous women (Primary Aim), 2) Determine the effect of immediate pushing on the rate of neonatal composite morbidity (Secondary Aim #1), and 3) Determine the impact of immediate versus delayed pushing on objective and subjective measures of maternal pelvic floor morbidity (Secondary Aim #2). They estimate that randomizing a total of 3184 women will provide adequate statistical power to detect meaningful differences in the primary and secondary outcomes.
详细描述
A. SPECIFIC AIMS
The central hypothesis is that immediate pushing in the second stage of labor increases spontaneous vaginal delivery, shortens duration of the second stage, and reduces adverse neonatal and maternal outcomes in nulliparous women. They will pursue the following specific aims:
1) Primary Aim: Assess the effectiveness of immediate pushing at complete cervical dilation on the rate of spontaneous vaginal delivery in nulliparous women. Hypothesis: Nulliparous women will have an increase in spontaneous vaginal delivery rates with immediate, as compared to delayed, pushing.
2) Secondary Aims: i.Determine the effect of immediate pushing on the rate of neonatal composite morbidity. Hypothesis: Immediate pushing will reduce the rate of neonatal composite morbidity, defined as one or more of: neonatal death, major neonatal injury, umbilical cord arterial acidosis, suspected neonatal sepsis, respiratory distress, transient tachypnea, meconium aspiration with pulmonary hypertension, hypoxic-ischemic encephalopathy, hypoglycemia, and need for hypothermia treatment.
ii.Determine the impact of immediate versus delayed pushing on objective and subjective measures of maternal pelvic floor morbidity. Hypothesis: Immediate pushing will be associated with a reduction in the rate of acute levator ani and anal sphincter muscle injury, and lower rates of pelvic floor disorders identified on subjective and objective clinical assessments.
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
- 是
入选标准
- •Singleton term pregnancy: gestational age ≥37 weeks
- •Nulliparous women
- •Neuraxial anesthesia: epidural or combined epidural-spinal anesthesia
排除标准
- •Preterm: gestational age <37 weeks (preterm infants have an a priori risk for adverse outcomes, which is driven more by gestational age than the timing of maternal pushing in the second stage)
- •Multiple gestation (incidence of multiple gestation is small and there are unique delivery considerations)
- •Multiparous women
- •Non-reassuring fetal heart rate tracing (will be an indication for expedited delivery)
- •Contraindication to vaginal delivery including: non-vertex presentation, placenta previa, prior classical cesarean, etc.
- •No neuraxial anesthesia: epidural or combined epidural-spinal anesthesia (subjects without adequate pain control tend to push involuntarily and cannot delay pushing)
- •Pregnancy complications requiring expedited delivery: severe preeclampsia, placental abruption, maternal cardiac disease
- •Fetal head visible at the introitus at complete cervical dilation
研究组 & 干预措施
Delayed pushing
干预措施: Delayed pushing (Procedure)
Immediate pushing
干预措施: Immediate pushing (Procedure)
结局指标
主要结局
Spontaneous vaginal delivery
时间窗: At delivery
Spontaneous vaginal delivery will be defined as delivery that occurs without the use of forceps, vacuum, or cesarean, as the primary outcome measure.
次要结局
- Rate and extent of acute levator ani muscle injury(At delivery, 1 - 5 days, 4 - 8 weeks, 5 - 7 months)
- Neonatal composite morbidity(At delivery)
- Rates of patient-reported symptoms of urinary incontinence, fecal incontinence, and pelvic organ prolapse on physical examination(1 - 5 days, 4 - 8 weeks, and 5 - 7 months)
研究者
Methodius Tuuli, MD, MPH
Assistant Professor
Washington University School of Medicine