Randomized Control Trial of Second Stage of Labor (RULES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Thomas Jefferson University
Information provided by (Responsible Party):
alexis gimovsky, Thomas Jefferson University
ClinicalTrials.gov Identifier:
First received: March 28, 2014
Last updated: May 11, 2015
Last verified: May 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 to reduce the primary cesarean delivery rate, without increasing 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 rate [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]
  • NICU admission [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (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
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
  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 (surgical skin preparation with povidone-iodine solution and prophylactic antibiotics).
  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 18-50. -

Exclusion Criteria:

  • Category 3 fetal heart tracing
  • major congenital anomalies
  • multiples
  • planned cesarean delivery
  • intrauterine fetal demise
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02101515

Contact: Alexis Gimovsky, MD 215-955-9200 alexis.gimovsky@jefferson.edu

United States, Pennsylvania
Thomas Jefferson University Hosptial Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Alexis Gimovsky, MD    215-955-9200    alexis.gimovsky@jefferson.edu   
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: May 11, 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 August 31, 2015