Trial Outcomes & Findings for Randomized Control Trial of Second Stage of Labor (NCT NCT02101515)
NCT ID: NCT02101515
Last Updated: 2018-10-26
Results Overview
Number of patients delivered by cesarean delivery for the extended labor group
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
At time of delivery, up to 4 hours of the second stage for "Extended group" and 3 hours for "Usual group"
Results posted on
2018-10-26
Participant Flow
Participant milestones
| Measure |
Usual Labor
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
n = 37
|
Extended
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
n = 41
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
41
|
|
Overall Study
COMPLETED
|
37
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Control Trial of Second Stage of Labor
Baseline characteristics by cohort
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
n = 37
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
n = 41
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.7 years
STANDARD_DEVIATION 5.4 • n=99 Participants
|
27.6 years
STANDARD_DEVIATION 4.7 • n=107 Participants
|
28.1 years
STANDARD_DEVIATION 5.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Epidural anesthesia
|
37 participants
n=99 Participants
|
41 participants
n=107 Participants
|
78 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Number of Patients Delivered by Cesarean
|
16 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Number of Newborns With Umbilical Artery pH < 7.10
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"Number of participants who experienced a postpartum hemorrhage
Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Postpartum Hemorrhage
|
3 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Operative Vaginal Delivery
|
14 Participants
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Spontaneous Vaginal Delivery
|
7 Participants
|
21 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time of delivery until maternal discharge, usually < 5 daysClinical diagnosis of postpartum endometritis of the mother
Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Endometritis
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time of delivery until maternal discharge, usually < 5 daysAny transfusion of packed red blood cells to the mother or any other blood products given.
Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Transfusion
|
0 participants
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"3rd or 4th degree laceration or cervical laceration diagnosed at delivery Third degree lacerations extend through the fascia and musculature of the perineal body and involve some or all of the fibers of the external anal sphincter (EAS) and/or the internal anal sphincter. Third degree lacerations are subclassified as follows: * 3a: \<50 percent of EAS thickness is torn * 3b: \>50 percent of EAS thickness is torn * 3c: IAS is torn (in addition to complete rupture of the EAS) * Fourth degree lacerations involve the perineal structures, EAS, IAS, and the rectal mucosa.
Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
3rd/4th Degree Laceration
|
1 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Number of Participants With Shoulder Dystocia
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Birth until neonatal dischargeOne neonate was analyzed per mother
Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Neonatal Intensive Care Unit Admission (Neonates)
|
14 Participants
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"Clinical diagnosis of Chorioamnionitis of the mother
Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Chorioamnionitis
|
13 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: until neonatal discharge, usually < 5 daysDiagnosed by neonatology, one neonate was analyzed per mother
Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Neonatal Sepsis (Neonate)
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time of deliveryOne neonate was analyzed per mother
Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Birth Weight (Neonate)
|
3506 grams
Standard Deviation 534
|
3437 grams
Standard Deviation 527
|
OTHER_PRE_SPECIFIED outcome
Timeframe: until discharge, usually < 5 daysDiagnosed by neonatology, one neonate was analyzed per mother
Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Neonatal Seizures (Neonate)
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: until neonatal discharge, usually < 5 daysone neonate was analyzed per mother
Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Neonatal Length of Stay (Neonate)
|
4.03 days
Standard Deviation 5.64
|
2.66 days
Standard Deviation 1.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: early neonatal mortality (within 7 days of birth).one neonate was analyzed per mother
Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Neonatal Mortality (Neonate)
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Until neonatal discharge, usually < 5 daysNumber of neonates who required continuous positive airway pressure or greater.
Outcome measures
| Measure |
Usual Labor
n=37 Participants
Immediate delivery after 3 hours with epidural or 2 hours without epidural
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
Extended
n=41 Participants
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.
Length of Second Stage: The experimental group will have one additional hour in the second stage of labor
|
|---|---|---|
|
Continuous Positive Airway Pressure or Greater (Neonate) Such as Intubation, Mechanical Ventilation, Nasal Intermittent Positive Pressure Ventilation, High-frequency Oscillatory Ventilation
|
3 Participants
|
1 Participants
|
Adverse Events
Usual Labor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Extended
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alexis Gimovsky, MD
George Washington University School of Medicine and Health Sciences
Phone: 2027412603
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place