Optimizing Management of the 2nd Stage of Labor: Multicenter Randomized Trial
Stopped early · Not applicable
Conditions studied: Pregnancy
In brief
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.
Key facts
- Study ID
- NCT02137200
- Run by
- Washington University School of Medicine
- People needed
- 2414
- Starts
- 2014-05-24
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2019-10-04
Who can join
Age: any. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Singleton term pregnancy: gestational age ≥37 weeks
- Nulliparous women
- Neuraxial anesthesia: epidural or combined epidural-spinal anesthesia
You may not qualify if…
- 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
Where it is running
- University of Alabama Medical Center — Birmingham, Alabama, United States
- Barnes Jewish Hospital — St Louis, Missouri, United States
- Missouri Baptist Hospital — St Louis, Missouri, United States
- Oregon Health Sciences University Medical Center — Portland, Oregon, United States
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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