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

NCT02137200 | Terminated DMC

• 2 other identifiers: IRB ID #:201312123R01HD077384-01A1
• Study Type: interventional
• Target: 2,414
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• Spontaneous vaginal delivery

  Spontaneous vaginal delivery will be defined as delivery that occurs without the use of forceps, vacuum, or cesarean, as the primary outcome measure.

  At delivery

Secondary Outcomes (3)

• Neonatal composite morbidity

  At delivery

• Rate and extent of acute levator ani muscle injury

  At delivery, 1 - 5 days, 4 - 8 weeks, 5 - 7 months

• 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

Other Outcomes (2)

• Patient satisfaction

  At delivery

• Economic analysis

  At delivery

Study Arms (2)

Delayed pushing

ACTIVE COMPARATOR

Procedure: Delayed pushing

Immediate pushing

EXPERIMENTAL

Procedure: Immediate pushing

Interventions

Immediate pushing PROCEDURE

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

Immediate pushing

Delayed pushing PROCEDURE

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.

Delayed pushing

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institutes of Health (NIH): collaborator

Study Sites (6)

University of Alabama Medical Center

Birmingham, Alabama, 35233, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Hospital

St Louis, Missouri, 63131, United States

Location

Oregon Health Sciences University Medical Center

Portland, Oregon, 97239, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (4)

• McKenzie CM, Woolfolk CL, Gregory WT, White AB, Tuuli MG, Tita ATN, Srinivas SK, Caughey AB, Arya LA, Lowder JL, Macones GA, Cahill AG, Richter HE. Three-Year Outcomes of Second-Stage Pushing Timing on Postpartum Pelvic Floor Morbidity. Obstet Gynecol. 2026 Feb 1;147(2):221-228. doi: 10.1097/AOG.0000000000006082. Epub 2025 Oct 2.

  PMID: 41037818 DERIVED

• Tuuli MG, Gregory WT, Arya LA, Lowder JL, Woolfolk C, Caughey AB, Srinivas SK, Tita ATN, Macones GA, Cahill AG, Richter HE. Effect of Second-Stage Pushing Timing on Postpartum Pelvic Floor Morbidity: A Randomized Controlled Trial. Obstet Gynecol. 2023 Feb 1;141(2):245-252. doi: 10.1097/AOG.0000000000005031. Epub 2023 Jan 4.

  PMID: 36603202 DERIVED

• Gregory WT, Cahill AG, Woolfolk C, Lowder JL, Caughey AB, Srinivas SK, Tita ATN, Tuuli MG, Richter HE. Impact of pushing timing on occult injury of levator ani: secondary analysis of a randomized trial. Am J Obstet Gynecol. 2022 May;226(5):718.e1-718.e10. doi: 10.1016/j.ajog.2022.02.020. Epub 2022 Feb 22.

  PMID: 35202591 DERIVED

• Cahill AG, Srinivas SK, Tita ATN, Caughey AB, Richter HE, Gregory WT, Liu J, Woolfolk C, Weinstein DL, Mathur AM, Macones GA, Tuuli MG. Effect of Immediate vs Delayed Pushing on Rates of Spontaneous Vaginal Delivery Among Nulliparous Women Receiving Neuraxial Analgesia: A Randomized Clinical Trial. JAMA. 2018 Oct 9;320(14):1444-1454. doi: 10.1001/jama.2018.13986.

  PMID: 30304425 DERIVED

Study Officials

• Alison G. Cahill, MD, MSCI

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Methodius G. Tuuli, MD, MPH

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 13, 2014
• Study Start: May 24, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 4, 2019

Record last verified: 2019-10

Locations

US (6)