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

NCT02137200 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2414

Last updated 2019-10-04

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

PROCEDURE

Immediate pushing

Women in this arm will be instructed to initiate pushing as soon as complete cervical dilation is documented.

PROCEDURE

Delayed pushing

Women assigned to delayed pushing will be instructed to wait for 60 minutes from complete cervical dilation before pushing. Women will be allowed to push earlier if they feel an irresistible urge to push, the fetal head is visible at the perineum, or the fetal heart tracing is non-reassuring.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

Principal Investigators

  • Alison G. Cahill, MD, MSCI · University of Texas at Austin

  • Methodius G. Tuuli, MD, MPH · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-24
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02137200 on ClinicalTrials.gov