Randomized Control Trial of Second Stage of Labor (RULES)
The hypothesis of this study is that extending the second stage of labor beyond current ACOG 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 to reduce the primary cesarean delivery rate, without increasing perinatal morbidity.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Control Trial of Usual Labor Versus Extended Second Stage|
- Cesarean Delivery Rate [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]
- postpartum hemorrhage [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]
- Cord pH [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]
- Operative vaginal delivery rate [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]
- NICU admission [ Time Frame: at time of delivery ] [ Designated as safety issue: No ]
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Placebo Comparator: Usual Labor
Immediate delivery after 3 hours with epidural or 2 hours without epidural
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.
Other: Length of Second Stage
The experimental group will have one additional hour in the second stage of labor
- Consent at the time of admission or in the office
- 2nd stage starts at full dilation
- Randomization occurs at 2 hours without epidural or 3 hours with epidural
- Randomization scheme is according to a predetermined computer-generated block randomization scheme with block sizes of 6,8 and12 (random blocks).
- 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.
- 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.
- Provider preference for cesarean delivery, operative vaginal delivery, continued pushing, with intention-to-treat analysis
- Those that require cesarean delivery - usual perioperative management (surgical skin preparation with povidone-iodine solution and prophylactic antibiotics).
- Early termination criteria: emergency cesarean delivery, category 3 fetal heart tracing
Please refer to this study by its ClinicalTrials.gov identifier: NCT02101515
|Contact: Alexis Gimovsky, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Thomas Jefferson University Hosptial||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Alexis Gimovsky, MD 215-955-9200 email@example.com|
|Principal Investigator:||Alexis Gimovsky, MD||Thomas Jefferson University|
|Study Chair:||Vincenzo Berghella, MD||Thomas Jefferson University|