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Randomized Control Trial of Second Stage of Labor

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ClinicalTrials.gov Identifier: NCT02101515
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : September 28, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Labor Complications Other: Length of Second Stage

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Usual Labor Versus Extended Second Stage
Study Start Date : March 2014
Primary Completion Date : July 2015
Study Completion Date : July 2015
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Cesarean Delivery Rate [ Time Frame: At time of delivery ]

Secondary Outcome Measures :
  1. postpartum hemorrhage [ Time Frame: at time of delivery ]
  2. Cord pH [ Time Frame: at time of delivery ]

Other Outcome Measures:
  1. Operative vaginal delivery [ Time Frame: at time of delivery ]
  2. NICU admission [ Time Frame: at time of delivery ]
  3. Transfusion [ Time Frame: at time of delivery until maternal discharge, usually < 5 days ]
    Any transfusion of packed red blood cells to the mother or any other blood products given.

  4. Chorioamnionitis [ Time Frame: at time of delivery ]
    Clinical diagnosis of Chorioamnionitis of the mother

  5. Endometritis [ Time Frame: at time of delivery until maternal discharge, usually < 5 days ]
    Clinical diagnosis of postpartum Endometritis of the mother

  6. Laceration [ Time Frame: at time of delivery ]
    3rd or 4th degree laceration or cervical laceration diagnosed at delivery.

  7. Neonatal Sepsis [ Time Frame: until neonatal discharge, usually < 5 days ]
    Diagnosed by neonatology

  8. Birth weight [ Time Frame: at time of delivery ]
  9. Neonatal seizures [ Time Frame: until discharge, usually < 5 days ]
    Diagnosed by neonatology

  10. Neonatal length of stay [ Time Frame: until neonatal discharge, usually < 5 days ]
  11. Shoulder dystocia [ Time Frame: at time of delivery ]
  12. Neonatal mortality [ Time Frame: early neonatal mortality (within 7 days of birth). ]
  13. CPAP or greater [ Time Frame: Until neonatal discharge, usually < 5 days ]
    As per NICU

  14. Spontaneous vaginal delivery [ Time Frame: at time of delivery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015

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

Additional relevant MeSH terms:
Obstetric Labor Complications
Pregnancy Complications