Randomized Control Trial of Second Stage of Labor

Not Applicable

Completed

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

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Usual Labor	Length of Second Stage	Immediate delivery after 3 hours with epidural or 2 hours without epidural
Extended	Length of Second Stage	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients Delivered by Cesarean	At time of delivery, up to 4 hours of the second stage for "Extended group" and 3 hours for "Usual group"	Number of patients delivered by cesarean delivery for the extended labor group

Secondary Outcome Measures

Name	Time	Method
Number of Newborns With Umbilical Artery pH < 7.10	at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"	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.
Postpartum Hemorrhage	at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"	Number of participants who experienced a postpartum hemorrhage