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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
42
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.
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.
Northwestern Memorial Hospital
Chicago, Illinois, United States
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
Time frame: From randomization until delivery, up to 5 hours
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From delivery until hospital discharge, up to 28 days of life