PROphylactic Manual RotatIon in the Second stagE of Labor

Study Overview
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Brief Summary
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This is a randomized controlled trial to determine whether prophylactic manual rotation for fetuses identified to have persistent occiput posterior or occiput transverse presentation (POP/OTP) at the initiation of the second stage of labor in nulliparous individuals reduces rates of operative delivery, second stage of labor duration, and resultant adverse clinical outcomes compared to standard management of the second stage of labor.

Detailed Description
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This is a randomized controlled trial in which nulliparous individuals with a term, singleton gestation who undergo a trial of labor with neuraxial anesthesia and have a fetus presenting with persistent occiput posterior or occiput transverse presentation (POP/OTP) confirmed by ultrasound at the initiation of the second stage of labor will be randomized to either prophylactic manual rotation or sham rotation. The study aims to evaluate whether prophylactic manual rotation reduces the incidence of operative delivery (a composite of cesarean and operative vaginal delivery), second stage of labor duration, and maternal and neonatal morbidity among nulliparous individuals with a fetus with POP/OTP at the initiation of the second stage of labor. Individuals will be screened for eligibility upon admission to Labor and Delivery and approached for potential recruitment with informed consent obtained on enrollment. Once women achieve complete cervical dilation and within the first fifteen minutes of commencement of pushing, a bedside ultrasound will be performed to determine the fetal position. Those with POP/OTP will be randomized at that time point to either prophylactic manual rotation or sham rotation. The patient's primary obstetrician will be blinded to the randomization arm. The electronic health record will be reviewed and used to assess trial outcomes. The study will enroll 350 individuals, powered to detect a 15% reduction in operative delivery (instrumental vaginal delivery or cesarean section) with prophylactic manual rotation of POP/OTP, from a baseline risk of 50% without manual rotation to 35% with prophylactic rotation at initiation of the second stage of labor.

Official Title
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PROphylactic Manual RotatIon in the Second stagE of Labor (PROMISE): a Randomized Controlled Trial

Conditions
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Labor Complication, Pregnancy Related

Intervention / Treatment
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* Procedure: Prophylactic manual rotation
* Procedure: Sham rotation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant Age 18 years or greater English-speaking Nulliparous Singleton gestation Planning a vaginal birth Have neuraxial anesthesia Term gestation (≥37 weeks' gestation) Ruptured membranes Complete cervical dilation Cephalic presenting fetus Fetus presenting with occiput posterior or occiput transverse position confirmed by ultrasound Exclusion Criteria: Pregnancies with intrauterine fetal demise Pregnancies affected by major fetal anomaly Maternal or fetal contraindication to vaginal delivery, including operative vaginal delivery Fetal malpresentation, including brow or face presentation Category III fetal heart rate tracing at time of randomization Duration of pushing already exceeding 15 minutes in the second stage of labor Lack of other inclusion criteria as described above

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prophylactic manual rotation<br>Prophylactic manual rotation involves a vaginal examination performed with an obstetric provider's hands to turn the baby from a position in which the baby's face is looking up in the direction of the ceiling (occiput posterior) or to the side (occiput transverse) to a position in which the baby's face is looking down in the direction of the mother's spine (occiput anterior). Prophylactic manual rotation will occur at the initiation of pushing once the individual achieves complete cervical dilation. | Procedure: Prophylactic manual rotation<br>* Prophylactic manual rotation, performed in the experimental arm, involves a vaginal examination performed with an obstetric provider's hands to turn the baby from a position in which the baby's face is looking up in the direction of the ceiling (occiput posterior) or to the side (occiput transverse) to a position in which the baby's face is looking down in the direction of the mother's spine (occiput anterior). Prophylactic manual rotation will occur at the initiation of pushing once the individual achieves complete cervical dilation, performed by a trained study investigator (M.D. or midwife) to maintain blinding of the patient's primary obstetrician.<br>|
| Sham Comparator: Sham rotation<br>Sham rotation involves a vaginal exam that obstetric providers commonly do with their hands to assess cervical dilation and fetal position during routine labor, and will occur at the initiation of pushing once the individual achieves complete cervical dilation. | Procedure: Sham rotation<br>* Sham rotation, performed in the comparator arm, involves a vaginal exam that obstetric providers commonly do with their hands to assess cervical dilation and fetal position during routine labor, and will occur at the initiation of pushing once the individual achieves complete cervical dilation. Duration of the vaginal exam for sham rotation will be consistent with that used for prophylactic manual rotation and will be performed by a trained study investigator (M.D. or midwife) to maintain blinding of the patient's primary obstetrician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants in each group who undergo operative delivery | Number of participants in each group who undergo a cesarean section or an instrumental delivery (vacuum or forceps) as a composite outcome | From randomization until delivery, up to 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants in each group who undergo operative vaginal delivery | Number of participants in each group who undergo an instrumental vaginal delivery with vacuum or forceps | From randomization until delivery, up to 5 hours | 
| Number of participants in each group who undergo cesarean delivery | Number of participants in each group who undergo a cesarean section | From randomization until delivery, up to 5 hours | 
| Number of minutes in the second stage of labor in each group | Number of minutes participants in each group spend in the second stage of labor | From randomization until delivery, up to 300 minutes | 
| Number of participants in each group with composite maternal morbidity | Number of participants in each group with a composite of the following individual adverse maternal outcomes: obstetric anal sphincter injury (i.e. 3rd or 4th degree perineal lacerations), postpartum hemorrhage (i.e. estimated blood loss as defined by >1000ml), blood product transfusion, intrapartum chorioamnionitis diagnosed in the second stage of labor, or postpartum endometritis | From randomization until hospital discharge, an expected average of 3 days | 
| Number of participants in each group with maternal intrapartum chorioamnionitis diagnosed in the second stage of labor | Number of participants in each group who are diagnosed with intrapartum chorioamnionitis during the second stage of labor as defined by fever greater than 100.4 Fahrenheit in the intrapartum period and at least one additional clinical factor (fundal tenderness, maternal tachycardia, fetal tachycardia, or purulent discharge) with initiation of a therapeutic antibiotic regimen in the second stage of labor | From randomization until delivery, up to 5 hours | 
| Number of participants in each group with postpartum endometritis | Number of participants in each group who experience postpartum endometritis as defined by fever greater than 100.4 Fahrenheit and one additional clinical factor (fundal tenderness or purulent lochia) in the postpartum period with the initiation of a therapeutic antibiotic regimen in the postpartum period | From delivery until hospital discharge, an expected average of 3 days | 
| Number of participants in each group with postpartum hemorrhage | Number of participants in each group with postpartum hemorrhage (i.e. estimated blood loss as defined by >1000ml) | From randomization until hospital discharge, an expected average of 3 days | 
| Number of participants in each group who require blood product transfusion | Number of participants in each group who require blood product transfusion | From randomization until hospital discharge, an expected average of 3 days | 
| Number of participants in each group who experience obstetric anal sphincter injury (i.e. a composite of 3rd or 4th degree perineal lacerations) | Number of participants in each group with 3rd or 4th degree perineal lacerations as a composite outcome | From randomization until delivery, up to 5 hours | 
| Number of participants in each group with composite severe neonatal morbidity | Number of participants in each group with neonates with the composite of the following individual adverse neonatal outcomes: 5-minute Apgar score <5, arterial cord pH ≤7.00 or base excess ≤-12 milliequivalents/L, shoulder dystocia, hypoxic-ischemic encephalopathy requiring hypothermic therapy or neonatal subgaleal or intracranial hemorrhage, neonatal intensive care unit (NICU) admission, or neonatal sepsis | From delivery until hospital discharge, up to 28 days of life | 
| Number of participants in each group who experience neonatal death | Number of participants in each group with neonates who experience neonatal death after delivery prior to hospital discharge | From delivery until hospital discharge, up to 28 days of life | 
| Number of participants in each group affected by neonatal intensive care unit (NICU) admission | Number of participants in each group with a neonate that requires neonatal intensive care unit (NICU) admission following delivery | From delivery until hospital discharge, up to 28 days of life | 
| Number of days a participant in each group has a neonate requiring neonatal intensive care unit (NICU) admission | Number of days a participant in each group has a neonate that is admitted to the neonatal intensive care unit (NICU) following delivery | From delivery until hospital discharge, up to 28 days of life | 
| Number of participants in each group with a neonate with neonatal 5-minute Apgar score <5 | Number of participants in each group with a neonate that has an Apgar score less than 5 at 5 minutes of life | From delivery up to 5 minutes of life | 
| Number of participants in each group with a neonate with neonatal umbilical arterial cord pH ≤7.00 or base excess ≤-12 milliequivalents/L | Number of participants in each group with a neonate that has an umbilical arterial cord pH less than or equal to 7.00 or base excess less than or equal to -12 milliequivalents/L as a composite outcome | At time of delivery | 
| Number of participants in each group who experiences intrapartum shoulder dystocia | Number of participants in each group that experiences a shoulder dystocia at delivery | From randomization until delivery, up to 5 hours | 
| Number of participants in each group with a neonate with neonatal hypoxic-ischemic encephalopathy requiring hypothermic therapy or neonatal subgaleal or intracranial hemorrhage | Number of participants in each group with a neonate that experiences development of hypoxic-ischemic encephalopathy requiring hypothermic therapy or development of subgaleal or intracranial hemorrhage as a result of birth trauma or other delivery event | From delivery until hospital discharge, up to 28 days of life | 
| Number of participants in each group with a neonate with neonatal sepsis | Number of participants in each group with a neonate that experiences neonatal sepsis as defined by pathogenic bacterial infection confirmed in blood or cerebrospinal fluid culture | From delivery until hospital discharge, up to 28 days of life |