Clinical trial NCT02101515: Randomized Control Trial of Second Stage of Labor
Official title: Randomized Control Trial of Usual Labor Versus Extended Second Stage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Complications
Keywords: randomized controlled trial
labor complications
cesarean section
second stage
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Delivered by Cesarean
timeFrame: At time of delivery, up to 4 hours of the second stage for "Extended group" and 3 hours for "Usual group"
Secondary outcomes:
measure: Number of Newborns With Umbilical Artery pH < 7.10
timeFrame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
measure: Postpartum Hemorrhage
timeFrame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
Other outcomes:
measure: Operative Vaginal Delivery
timeFrame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
measure: Spontaneous Vaginal Delivery
timeFrame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
measure: Endometritis
timeFrame: at time of delivery until maternal discharge, usually < 5 days
measure: Transfusion
timeFrame: at time of delivery until maternal discharge, usually < 5 days
measure: 3rd/4th Degree Laceration
timeFrame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
measure: Number of Participants With Shoulder Dystocia
timeFrame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
measure: Neonatal Intensive Care Unit Admission (Neonates)
timeFrame: Birth until neonatal discharge
measure: Chorioamnionitis
timeFrame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
measure: Neonatal Sepsis (Neonate)
timeFrame: until neonatal discharge, usually < 5 days
measure: Birth Weight (Neonate)
timeFrame: at time of delivery
measure: Neonatal Seizures (Neonate)
timeFrame: until discharge, usually < 5 days
measure: Neonatal Length of Stay (Neonate)
timeFrame: until neonatal discharge, usually < 5 days
measure: Neonatal Mortality (Neonate)
timeFrame: early neonatal mortality (within 7 days of birth).
measure: Continuous Positive Airway Pressure or Greater (Neonate) Such as Intubation, Mechanical Ventilation, Nasal Intermittent Positive Pressure Ventilation, High-frequency Oscillatory Ventilation
timeFrame: Until neonatal discharge, usually < 5 days
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hosptial
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Alexis Gimovsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Vincenzo Berghella, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.