Randomized Control Trial of Second Stage of Labor

Thomas Jefferson University

Status: Completed

Conditions: Labor Complications

Treatments: Other: Length of Second Stage

Study type: Interventional

Funder types: Other

Identifiers

NCT02101515

13D.590

Details and patient eligibility

About

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.

Full 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

Enrollment: 78 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups, including a placebo group

Usual Labor

Placebo Comparator group

Description:

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

Treatment:

Other: Length of Second Stage

Extended

Experimental group

Description:

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.

Treatment:

Other: Length of Second Stage