Clinical trial NCT05175040: PROphylactic Manual RotatIon in the Second stagE of Labor
Official title: PROphylactic Manual RotatIon in the Second stagE of Labor (PROMISE): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Labor Complication
Pregnancy Related
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants in each group who undergo operative delivery
timeFrame: From randomization until delivery, up to 5 hours
Secondary outcomes:
measure: Number of participants in each group who undergo operative vaginal delivery
timeFrame: From randomization until delivery, up to 5 hours
measure: Number of participants in each group who undergo cesarean delivery
timeFrame: From randomization until delivery, up to 5 hours
measure: Number of minutes in the second stage of labor in each group
timeFrame: From randomization until delivery, up to 300 minutes
measure: Number of participants in each group with composite maternal morbidity
timeFrame: From randomization until hospital discharge, an expected average of 3 days
measure: Number of participants in each group with maternal intrapartum chorioamnionitis diagnosed in the second stage of labor
timeFrame: From randomization until delivery, up to 5 hours
measure: Number of participants in each group with postpartum endometritis
timeFrame: From delivery until hospital discharge, an expected average of 3 days
measure: Number of participants in each group with postpartum hemorrhage
timeFrame: From randomization until hospital discharge, an expected average of 3 days
measure: Number of participants in each group who require blood product transfusion
timeFrame: From randomization until hospital discharge, an expected average of 3 days
measure: Number of participants in each group who experience obstetric anal sphincter injury (i.e. a composite of 3rd or 4th degree perineal lacerations)
timeFrame: From randomization until delivery, up to 5 hours
measure: Number of participants in each group with composite severe neonatal morbidity
timeFrame: From delivery until hospital discharge, up to 28 days of life
measure: Number of participants in each group who experience neonatal death
timeFrame: From delivery until hospital discharge, up to 28 days of life
measure: Number of participants in each group affected by neonatal intensive care unit (NICU) admission
timeFrame: From delivery until hospital discharge, up to 28 days of life
measure: Number of days a participant in each group has a neonate requiring neonatal intensive care unit (NICU) admission
timeFrame: From delivery until hospital discharge, up to 28 days of life
measure: Number of participants in each group with a neonate with neonatal 5-minute Apgar score <5
timeFrame: From delivery up to 5 minutes of life
measure: Number of participants in each group with a neonate with neonatal umbilical arterial cord pH ≤7.00 or base excess ≤-12 milliequivalents/L
timeFrame: At time of delivery
measure: Number of participants in each group who experiences intrapartum shoulder dystocia
timeFrame: From randomization until delivery, up to 5 hours
measure: Number of participants in each group with a neonate with neonatal hypoxic-ischemic encephalopathy requiring hypothermic therapy or neonatal subgaleal or intracranial hemorrhage
timeFrame: From delivery until hospital discharge, up to 28 days of life
measure: Number of participants in each group with a neonate with neonatal sepsis
timeFrame: From delivery until hospital discharge, up to 28 days of life
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Stephanie Fisher, MD MPH
role: STUDY_DIRECTOR
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