Randomized Control Trial of Second Stage of Labor

Labor Complications Clinical Trial

Official title: Randomized Control Trial of Usual Labor Versus Extended Second Stage

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Labor Complications
• Obstetric Labor Complications

• NCT number: NCT02101515
• Study type: Interventional
• Source: Thomas Jefferson University
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Completion date: July 2015