Randomized Control Trial of Second Stage of Labor

Randomized Control Trial of Usual Labor Versus Extended Second Stage

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.

Study Overview

• Status: Completed
• Conditions: Labor Complications
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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
• Trial of labor after cesarean

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Newborns With Umbilical Artery pH < 7.10	Umbilical artery pH is a marker for adverse neurological outcomes. Umbilical artery pH <7.10 has been proposed as a threshold for identifying fetuses who might develop pathologic fetal acidosis and fetal injury.	at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
Postpartum Hemorrhage	Number of participants who experienced a postpartum hemorrhage	at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Clinical diagnosis of postpartum endometritis of the mother	at time of delivery until maternal discharge, usually < 5 days
Transfusion	Any transfusion of packed red blood cells to the mother or any other blood products given.	at time of delivery until maternal discharge, usually < 5 days
3rd/4th Degree Laceration	3rd or 4th degree laceration or cervical laceration diagnosed at delivery Third degree lacerations extend through the fascia and musculature of the perineal body and involve some or all of the fibers of the external anal sphincter (EAS) and/or the internal anal sphincter. Third degree lacerations are subclassified as follows: 3a: <50 percent of EAS thickness is torn; 3b: >50 percent of EAS thickness is torn; 3c: IAS is torn (in addition to complete rupture of the EAS)Fourth degree lacerations involve the perineal structures, EAS, IAS, and the rectal mucosa.	at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
Number of Participants With Shoulder Dystocia		at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
Neonatal Intensive Care Unit Admission (Neonates)	One neonate was analyzed per mother	Birth until neonatal discharge
Chorioamnionitis	Clinical diagnosis of Chorioamnionitis of the mother	at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
Neonatal Sepsis (Neonate)	Diagnosed by neonatology, one neonate was analyzed per mother	until neonatal discharge, usually < 5 days
Birth Weight (Neonate)	One neonate was analyzed per mother	at time of delivery
Neonatal Seizures (Neonate)	Diagnosed by neonatology, one neonate was analyzed per mother	until discharge, usually < 5 days
Neonatal Length of Stay (Neonate)	one neonate was analyzed per mother	until neonatal discharge, usually < 5 days
Neonatal Mortality (Neonate)	one neonate was analyzed per mother	early neonatal mortality (within 7 days of birth).
Continuous Positive Airway Pressure or Greater (Neonate) Such as Intubation, Mechanical Ventilation, Nasal Intermittent Positive Pressure Ventilation, High-frequency Oscillatory Ventilation	Number of neonates who required continuous positive airway pressure or greater.	Until neonatal discharge, usually < 5 days

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Alexis Gimovsky, MD, Thomas Jefferson University; Study Chair: Vincenzo Berghella, MD, Thomas Jefferson University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: March 28, 2014
• First Submitted That Met QC Criteria: March 28, 2014
• First Posted (Estimate): April 2, 2014

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: January 22, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: randomized controlled trial; cesarean section; labor complications; second stage
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications
• Other Study ID Numbers: 13D.590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Please contact Dr. Gimovsky at agimovsky@mfa.gwu.edu