Randomized Control Trial of Second Stage of Labor

NCT02101515 | Completed Results

• 1 other identifier: 13D.590
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of this study is that extending the second stage of labor beyond current American College of Obstetricians and Gynecologists suggestions can reduce the cesarean delivery rate. The cesarean delivery rate in the United States is around 30 percent. This is a number that continues to be increasing over the last few decades and will continue to climb. Each subsequent cesarean section puts the mother and baby at increased risk for postpartum hemorrhage, bowel and bladder injury, abnormal placentation, febrile morbidity and death. The most common reason for a cesarean delivery is a repeat cesarean delivery. One way to reduce this number is to prevent the first cesarean delivery. The aim of this study is evaluate if extending the second stage of labor affects the cesarean delivery rate and subsequent perinatal morbidity.

Conditions

Labor Complications

Keywords

randomized controlled trial; labor complications; cesarean section; second stage

Outcome Measures

Primary Outcomes (1)

• Number of Patients Delivered by Cesarean

  Number of patients delivered by cesarean delivery for the extended labor group

  At time of delivery, up to 4 hours of the second stage for "Extended group" and 3 hours for "Usual group"

Secondary Outcomes (2)

• Number of Newborns With Umbilical Artery pH < 7.10

  at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"

• Postpartum Hemorrhage

  at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"

Other Outcomes (14)

• Operative Vaginal Delivery

  at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"

• Spontaneous Vaginal Delivery

  at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"

• Endometritis

  at time of delivery until maternal discharge, usually < 5 days

Study Arms (2)

Usual Labor

PLACEBO COMPARATOR

Immediate delivery after 3 hours with epidural or 2 hours without epidural

Other: Length of Second Stage

Extended

EXPERIMENTAL

Immediate delivery after 4 hours with an epidural or 3 hours without an epidural Intervention: one additional hour for the second stage of labor Length of second stage in extended arm is 3 hours without epidural and 4 hours with epidural.

Other: Length of Second Stage

Interventions

Length of Second Stage OTHER

The experimental group will have one additional hour in the second stage of labor

Extended; Usual Labor

Eligibility Criteria

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

You may qualify if:

• Nulliparous women
• singleton pregnancies
• cephalic presentation
• weeks
• age 18 and older

You may not qualify if:

• Category 3 fetal heart tracing
• major congenital anomalies
• multiples
• planned cesarean delivery
• intrauterine fetal demise
• Trial of labor after cesarean

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hosptial

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

• Gimovsky AC, Phillips JM, Amero M, Levine J, Berghella V. Prolonged second stage effect on pelvic floor dysfunction: a follow up survey to a randomized controlled trial. J Matern Fetal Neonatal Med. 2022 Dec;35(25):5520-5525. doi: 10.1080/14767058.2021.1887122. Epub 2021 Feb 14.

  PMID: 33586572 DERIVED

• Gimovsky AC, Berghella V. Randomized controlled trial of prolonged second stage: extending the time limit vs usual guidelines. Am J Obstet Gynecol. 2016 Mar;214(3):361.e1-6. doi: 10.1016/j.ajog.2015.12.042.

  PMID: 26928148 DERIVED

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Alexis Gimovsky, MD
• Organization: George Washington University School of Medicine and Health Sciences

agimovsk@mfa.gwu.edu

2027412603

Study Officials

• Alexis Gimovsky, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Vincenzo Berghella, MD

  Thomas Jefferson University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Fellow in Maternal Fetal Medicine

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 2, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 26, 2018
• Results First Posted: October 26, 2018

Record last verified: 2018-01

Locations

US (1)