Optimizing Management of the 2nd Stage of Labor: Multicenter Randomized Trial

Status: Terminated
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: t
View:

• Singleton term pregnancy: gestational age ≥37 weeks

• Nulliparous women

• Neuraxial anesthesia: epidural or combined epidural-spinal anesthesia

Locations
United States
Alabama
University of Alabama Medical Center
Birmingham
Missouri
Barnes Jewish Hospital
Saint Louis
Missouri Baptist Hospital
Saint Louis
Oregon
Oregon Health Sciences University Medical Center
Portland
Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia
Pennsylvania Hospital
Philadelphia
Time Frame
Start Date: 2014-05-24
Completion Date: 2017-12
Participants
Target number of participants: 2414
Treatments
Active_comparator: Delayed pushing
Experimental: Immediate pushing
Sponsors
Leads: Washington University School of Medicine
Collaborators: National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov