N/A
N=78
Randomized Control Trial of Second Stage of Labor
Labor Complications
Bottom Line
View on ClinicalTrials.gov: NCT02101515 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Number of Patients Delivered by Cesarean — 16; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Length of Second Stage (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Thomas Jefferson University
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Delivered by Cesarean |
16; 8 | — |
| SECONDARY Number of Newborns With Umbilical Artery pH < 7.10 |
0; 0 | — |
| SECONDARY Postpartum Hemorrhage |
3; 8 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02101515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.