PROphylactic Manual RotatIon in the Second stagE of Labor (PROMISE)

Northwestern University

Status: Terminated

Conditions: Pregnancy Related; Labor Complication

Treatments: Procedure: Prophylactic manual rotation; Procedure: Sham rotation

Study type: Interventional

Funder types: Other

Identifiers

NCT05175040

00215006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Prophylactic manual rotation

Experimental group

Description:

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.

Treatment:

Procedure: Prophylactic manual rotation

Sham rotation

Sham Comparator group

Description:

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.

Treatment:

Procedure: Sham rotation