Labor Complications
Conditions
Keywords
randomized controlled trial, labor complications, cesarean section, second stage
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
Interventions
OTHERLength of Second Stage
The experimental group will have one additional hour in the second stage of labor
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Transfusion | at time of delivery until maternal discharge, usually < 5 days | Any transfusion of packed red blood cells to the mother or any other blood products given. |
| 3rd/4th Degree Laceration | 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. |
| Number of Participants With Shoulder Dystocia | at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual | — |
| Neonatal Intensive Care Unit Admission (Neonates) | Birth until neonatal discharge | One neonate was analyzed per mother |
| Chorioamnionitis | at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual | Clinical diagnosis of Chorioamnionitis of the mother |
| Operative Vaginal Delivery | at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual | — |
| Birth Weight (Neonate) | at time of delivery | One neonate was analyzed per mother |
| Neonatal Seizures (Neonate) | until discharge, usually < 5 days | Diagnosed by neonatology, one neonate was analyzed per mother |
| Neonatal Length of Stay (Neonate) | until neonatal discharge, usually < 5 days | one neonate was analyzed per mother |
| Neonatal Mortality (Neonate) | early neonatal mortality (within 7 days of birth). | one neonate was analyzed per mother |
| Continuous Positive Airway Pressure or Greater (Neonate) Such as Intubation, Mechanical Ventilation, Nasal Intermittent Positive Pressure Ventilation, High-frequency Oscillatory Ventilation | Until neonatal discharge, usually < 5 days | Number of neonates who required continuous positive airway pressure or greater. |
| Neonatal Sepsis (Neonate) | until neonatal discharge, usually < 5 days | Diagnosed by neonatology, one neonate was analyzed per mother |
| Spontaneous Vaginal Delivery | at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual | — |
| Endometritis | at time of delivery until maternal discharge, usually < 5 days | Clinical diagnosis of postpartum endometritis of the mother |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 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 | 41 |
| Total | 78 |
Baseline characteristics
| Characteristic | Usual Labor | Extended | Total |
|---|---|---|---|
| Age, Continuous | 28.7 years STANDARD_DEVIATION 5.4 | 27.6 years STANDARD_DEVIATION 4.7 | 28.1 years STANDARD_DEVIATION 5 |
| Epidural anesthesia | 37 participants | 41 participants | 78 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 11 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 11 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 18 Participants | 35 Participants |
| Sex: Female, Male Female | 37 Participants | 41 Participants | 78 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 41 |
| serious Total, serious adverse events | 0 / 37 | 0 / 41 |
Outcome results
Primary
Number of Patients Delivered by Cesarean
Number of patients delivered by cesarean delivery for the extended labor group
Time frame: At time of delivery, up to 4 hours of the second stage for Extended group and 3 hours for Usual group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Labor | Number of Patients Delivered by Cesarean | 16 Participants |
| Extended | Number of Patients Delivered by Cesarean | 8 Participants |
95% CI: [0.22, 0.93]
Secondary
Number of Newborns With Umbilical Artery pH < 7.10
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.
Time frame: at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Labor | Number of Newborns With Umbilical Artery pH < 7.10 | 0 Participants |
| Extended | Number of Newborns With Umbilical Artery pH < 7.10 | 0 Participants |
Secondary
Postpartum Hemorrhage
Number of participants who experienced a postpartum hemorrhage
Time frame: at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Labor | Postpartum Hemorrhage | 3 Participants |
| Extended | Postpartum Hemorrhage | 8 Participants |
95% CI: [0.67, 8.4]
Other Pre-specified
3rd/4th Degree Laceration
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.
Time frame: at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Labor | 3rd/4th Degree Laceration | 1 Participants |
| Extended | 3rd/4th Degree Laceration | 6 Participants |
95% CI: [0.68, 42.9]
Other Pre-specified
Birth Weight (Neonate)
One neonate was analyzed per mother
Time frame: at time of delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Labor | Birth Weight (Neonate) | 3506 grams | Standard Deviation 534 |
| Extended | Birth Weight (Neonate) | 3437 grams | Standard Deviation 527 |
p-value: 0.6t-test, 2 sided
Other Pre-specified
Chorioamnionitis
Clinical diagnosis of Chorioamnionitis of the mother
Time frame: at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Labor | Chorioamnionitis | 13 Participants |
| Extended | Chorioamnionitis | 11 Participants |
95% CI: [0.39, 1.49]
Other Pre-specified
Continuous Positive Airway Pressure or Greater (Neonate) Such as Intubation, Mechanical Ventilation, Nasal Intermittent Positive Pressure Ventilation, High-frequency Oscillatory Ventilation
Number of neonates who required continuous positive airway pressure or greater.
Time frame: Until neonatal discharge, usually < 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Labor | Continuous Positive Airway Pressure or Greater (Neonate) Such as Intubation, Mechanical Ventilation, Nasal Intermittent Positive Pressure Ventilation, High-frequency Oscillatory Ventilation | 3 Participants |
| Extended | Continuous Positive Airway Pressure or Greater (Neonate) Such as Intubation, Mechanical Ventilation, Nasal Intermittent Positive Pressure Ventilation, High-frequency Oscillatory Ventilation | 1 Participants |
95% CI: [0.03, 2.77]
Other Pre-specified
Endometritis
Clinical diagnosis of postpartum endometritis of the mother
Time frame: at time of delivery until maternal discharge, usually < 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Labor | Endometritis | 1 Participants |
| Extended | Endometritis | 1 Participants |
95% CI: [0.06, 13.92]
Other Pre-specified
Neonatal Intensive Care Unit Admission (Neonates)
One neonate was analyzed per mother
Time frame: Birth until neonatal discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Labor | Neonatal Intensive Care Unit Admission (Neonates) | 14 Participants |
| Extended | Neonatal Intensive Care Unit Admission (Neonates) | 13 Participants |
95% CI: [0.46, 1.54]
Other Pre-specified
Neonatal Length of Stay (Neonate)
one neonate was analyzed per mother
Time frame: until neonatal discharge, usually < 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Labor | Neonatal Length of Stay (Neonate) | 4.03 days | Standard Deviation 5.64 |
| Extended | Neonatal Length of Stay (Neonate) | 2.66 days | Standard Deviation 1.02 |
Other Pre-specified
Neonatal Mortality (Neonate)
one neonate was analyzed per mother
Time frame: early neonatal mortality (within 7 days of birth).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Labor | Neonatal Mortality (Neonate) | 0 Participants |
| Extended | Neonatal Mortality (Neonate) | 0 Participants |
Other Pre-specified
Neonatal Seizures (Neonate)
Diagnosed by neonatology, one neonate was analyzed per mother
Time frame: until discharge, usually < 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Labor | Neonatal Seizures (Neonate) | 0 Participants |
| Extended | Neonatal Seizures (Neonate) | 0 Participants |
Other Pre-specified
Neonatal Sepsis (Neonate)
Diagnosed by neonatology, one neonate was analyzed per mother
Time frame: until neonatal discharge, usually < 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Labor | Neonatal Sepsis (Neonate) | 0 Participants |
| Extended | Neonatal Sepsis (Neonate) | 0 Participants |
Other Pre-specified
Number of Participants With Shoulder Dystocia
Time frame: at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Labor | Number of Participants With Shoulder Dystocia | 0 Participants |
| Extended | Number of Participants With Shoulder Dystocia | 1 Participants |
Other Pre-specified
Operative Vaginal Delivery
Time frame: at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Labor | Operative Vaginal Delivery | 14 Participants |
| Extended | Operative Vaginal Delivery | 12 Participants |
95% CI: [0.41, 1.45]
Other Pre-specified
Spontaneous Vaginal Delivery
Time frame: at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Labor | Spontaneous Vaginal Delivery | 7 Participants |
| Extended | Spontaneous Vaginal Delivery | 21 Participants |
95% CI: [1.3, 5.62]
Other Pre-specified
Transfusion
Any transfusion of packed red blood cells to the mother or any other blood products given.
Time frame: at time of delivery until maternal discharge, usually < 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Labor | Transfusion | 0 participants |
| Extended | Transfusion | 1 participants |