Randomized Control Trial of Second Stage of Labor

This study has been completed.
Information provided by (Responsible Party):
alexis gimovsky, Thomas Jefferson University
ClinicalTrials.gov Identifier:
First received: March 28, 2014
Last updated: September 25, 2015
Last verified: September 2015
The hypothesis of this study is that extending the second stage of labor beyond current ACOG 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.

Condition Intervention
Labor Complications
Other: Length of Second Stage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Usual Labor Versus Extended Second Stage

Resource links provided by NLM:

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Cesarean Delivery Rate [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • postpartum hemorrhage [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]
  • Cord pH [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Operative vaginal delivery [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]
  • NICU admission [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]
  • Transfusion [ Time Frame: at time of delivery until maternal discharge, usually < 5 days ] [ Designated as safety issue: Yes ]
    Any transfusion of packed red blood cells to the mother or any other blood products given.

  • Chorioamnionitis [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]
    Clinical diagnosis of Chorioamnionitis of the mother

  • Endometritis [ Time Frame: at time of delivery until maternal discharge, usually < 5 days ] [ Designated as safety issue: No ]
    Clinical diagnosis of postpartum Endometritis of the mother

  • Laceration [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]
    3rd or 4th degree laceration or cervical laceration diagnosed at delivery.

  • Neonatal Sepsis [ Time Frame: until neonatal discharge, usually < 5 days ] [ Designated as safety issue: No ]
    Diagnosed by neonatology

  • Birth weight [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]
  • Neonatal seizures [ Time Frame: until discharge, usually < 5 days ] [ Designated as safety issue: No ]
    Diagnosed by neonatology

  • Neonatal length of stay [ Time Frame: until neonatal discharge, usually < 5 days ] [ Designated as safety issue: No ]
  • Shoulder dystocia [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]
  • Neonatal mortality [ Time Frame: early neonatal mortality (within 7 days of birth). ] [ Designated as safety issue: Yes ]
  • CPAP or greater [ Time Frame: Until neonatal discharge, usually < 5 days ] [ Designated as safety issue: No ]
    As per NICU

  • Spontaneous vaginal delivery [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: March 2014
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Usual Labor
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Other: Length of Second Stage
The experimental group will have one additional hour in the second stage of labor
Experimental: Extended

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

Detailed Description:
  1. Consent at the time of admission or in the office
  2. 2nd stage starts at full dilation
  3. Randomization occurs at 2 hours without epidural or 3 hours with epidural, stratified by epidural status
  4. Randomization scheme is according to a predetermined computer-generated block randomization scheme with block sizes of 6,8 and12 (random blocks).
  5. Sequentially numbered and sealed opaque envelopes prepared according to the randomization scheme and delivered to a secure container in labor and delivery suite to maintain concealed treatment allocation.
  6. At the 3 hour mark, the next number envelope is pulled and opened by the physician/nurse to reveal the designated group. At this point the patient is considered randomized.
  7. Provider preference for cesarean delivery, operative vaginal delivery, continued pushing, with intention-to-treat analysis
  8. Those that require cesarean delivery - usual perioperative management
  9. Early termination criteria: emergency cesarean delivery, category 3 fetal heart tracing

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Nulliparous women
  • singleton pregnancies
  • cephalic presentation
  • 36.0-41.6 weeks
  • age 18 and older

Exclusion Criteria:

  • Category 3 fetal heart tracing
  • major congenital anomalies
  • multiples
  • planned cesarean delivery
  • intrauterine fetal demise
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02101515

United States, Pennsylvania
Thomas Jefferson University Hosptial
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Principal Investigator: Alexis Gimovsky, MD Thomas Jefferson University
Study Chair: Vincenzo Berghella, MD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: alexis gimovsky, Fellow in Maternal Fetal Medicine, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02101515     History of Changes
Other Study ID Numbers: 13D.590 
Study First Received: March 28, 2014
Last Updated: September 25, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
randomized controlled trial
labor complications
cesarean section
second stage

Additional relevant MeSH terms:
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on February 09, 2016