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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Labor | Placebo Comparator | Immediate delivery after 3 hours with epidural or 2 hours without epidural |
|
| Extended | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Length of Second Stage | Other | The experimental group will have one additional hour in the second stage of labor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Delivered by Cesarean | Number of patients delivered by cesarean delivery for the extended labor group | At time of delivery, up to 4 hours of the second stage for "Extended group" and 3 hours for "Usual group" |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual" |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Vaginal Delivery | at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual" | |
| Spontaneous Vaginal Delivery | at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual" |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexis Gimovsky, MD | Thomas Jefferson University | Principal Investigator |
| Vincenzo Berghella, MD | Thomas Jefferson University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hosptial | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33586572 | Derived | Gimovsky AC, Phillips JM, Amero M, Levine J, Berghella V. Prolonged second stage effect on pelvic floor dysfunction: a follow up survey to a randomized controlled trial. J Matern Fetal Neonatal Med. 2022 Dec;35(25):5520-5525. doi: 10.1080/14767058.2021.1887122. Epub 2021 Feb 14. | |
| 26928148 | Derived | Gimovsky AC, Berghella V. Randomized controlled trial of prolonged second stage: extending the time limit vs usual guidelines. Am J Obstet Gynecol. 2016 Mar;214(3):361.e1-6. doi: 10.1016/j.ajog.2015.12.042. |
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Please contact Dr. Gimovsky at agimovsky@mfa.gwu.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Extended |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Delivered by Cesarean | Number of patients delivered by cesarean delivery for the extended labor group | Posted | Count of Participants | Participants | At time of delivery, up to 4 hours of the second stage for "Extended group" and 3 hours for "Usual group" |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexis Gimovsky, MD | George Washington University School of Medicine and Health Sciences | 2027412603 | agimovsk@mfa.gwu.edu |
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| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Postpartum Hemorrhage | Number of participants who experienced a postpartum hemorrhage | at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual" |
| Endometritis | Clinical diagnosis of postpartum endometritis of the mother | at time of delivery until maternal discharge, usually < 5 days |
| Transfusion | Any transfusion of packed red blood cells to the mother or any other blood products given. | at time of delivery until maternal discharge, usually < 5 days |
| 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:
| at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual" |
| 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) | One neonate was analyzed per mother | Birth until neonatal discharge |
| Chorioamnionitis | Clinical diagnosis of Chorioamnionitis of the mother | at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual" |
| Neonatal Sepsis (Neonate) | Diagnosed by neonatology, one neonate was analyzed per mother | until neonatal discharge, usually < 5 days |
| Birth Weight (Neonate) | One neonate was analyzed per mother | at time of delivery |
| Neonatal Seizures (Neonate) | Diagnosed by neonatology, one neonate was analyzed per mother | until discharge, usually < 5 days |
| Neonatal Length of Stay (Neonate) | one neonate was analyzed per mother | until neonatal discharge, usually < 5 days |
| Neonatal Mortality (Neonate) | one neonate was analyzed per mother | early neonatal mortality (within 7 days of birth). |
| 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. | Until neonatal discharge, usually < 5 days |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Epidural anesthesia | Number | participants |
|
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|
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| 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. | Posted | Count of Participants | Participants | at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual" |
|
|
|
| Secondary | Postpartum Hemorrhage | Number of participants who experienced a postpartum hemorrhage | Posted | Count of Participants | Participants | at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual" |
|
|
|
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| Other Pre-specified | Operative Vaginal Delivery | Posted | Count of Participants | Participants | at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual" |
|
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|
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| Other Pre-specified | Spontaneous Vaginal Delivery | Posted | Count of Participants | Participants | at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual" |
|
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| Other Pre-specified | Endometritis | Clinical diagnosis of postpartum endometritis of the mother | Posted | Count of Participants | Participants | at time of delivery until maternal discharge, usually < 5 days |
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| Other Pre-specified | Transfusion | Any transfusion of packed red blood cells to the mother or any other blood products given. | Posted | Number | participants | at time of delivery until maternal discharge, usually < 5 days |
|
|
|
| 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:
| Posted | Count of Participants | Participants | at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual" |
|
|
|
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| Other Pre-specified | Number of Participants With Shoulder Dystocia | Posted | Count of Participants | Participants | at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual" |
|
|
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| Other Pre-specified | Neonatal Intensive Care Unit Admission (Neonates) | One neonate was analyzed per mother | Posted | Count of Participants | Participants | Birth until neonatal discharge |
|
|
|
|
| Other Pre-specified | Chorioamnionitis | Clinical diagnosis of Chorioamnionitis of the mother | Posted | Count of Participants | Participants | at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual" |
|
|
|
|
| Other Pre-specified | Neonatal Sepsis (Neonate) | Diagnosed by neonatology, one neonate was analyzed per mother | Posted | Count of Participants | Participants | until neonatal discharge, usually < 5 days |
|
|
|
| Other Pre-specified | Birth Weight (Neonate) | One neonate was analyzed per mother | Posted | Mean | Standard Deviation | grams | at time of delivery |
|
|
|
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| Other Pre-specified | Neonatal Seizures (Neonate) | Diagnosed by neonatology, one neonate was analyzed per mother | Posted | Count of Participants | Participants | until discharge, usually < 5 days |
|
|
|
| Other Pre-specified | Neonatal Length of Stay (Neonate) | one neonate was analyzed per mother | Posted | Mean | Standard Deviation | days | until neonatal discharge, usually < 5 days |
|
|
|
| Other Pre-specified | Neonatal Mortality (Neonate) | one neonate was analyzed per mother | Posted | Count of Participants | Participants | early neonatal mortality (within 7 days of birth). |
|
|
|
| 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. | Posted | Count of Participants | Participants | Until neonatal discharge, usually < 5 days |
|
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | 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 | 0 | 41 | 0 | 41 |
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