Randomized Control Trial of Second Stage of Labor

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-07-31

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.

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Detailed Description

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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

Conditions

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Labor Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Labor

Immediate delivery after 3 hours with epidural or 2 hours without epidural

Group Type PLACEBO_COMPARATOR

Length of Second Stage

Intervention Type OTHER

The experimental group will have one additional hour in the second stage of labor

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.

Group Type EXPERIMENTAL

Length of Second Stage

Intervention Type OTHER

The experimental group will have one additional hour in the second stage of labor

Interventions

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Length of Second Stage

The experimental group will have one additional hour in the second stage of labor

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes