Randomized Control Trial of Second Stage of Labor

Study Overview
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Brief Summary
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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
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Consent at the time of admission or in the office 2nd stage starts at full dilation Randomization occurs at 2 hours without epidural or 3 hours with epidural, stratified by epidural status Randomization scheme is according to a predetermined computer-generated block randomization scheme with block sizes of 6,8 and12 (random blocks). 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. 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. Provider preference for cesarean delivery, operative vaginal delivery, continued pushing, with intention-to-treat analysis Those that require cesarean delivery - usual perioperative management Early termination criteria: emergency cesarean delivery, category 3 fetal heart tracing

Official Title
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Randomized Control Trial of Usual Labor Versus Extended Second Stage

Conditions
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Labor Complications

Intervention / Treatment
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* Other: Length of Second Stage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Usual Labor<br>Immediate delivery after 3 hours with epidural or 2 hours without epidural | Other: Length of Second Stage<br>* The experimental group will have one additional hour in the second stage of labor<br>|
| Experimental: Extended<br>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<br>* The experimental group will have one additional hour in the second stage of labor<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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second stage, randomized controlled trial, labor complications, cesarean section