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PROphylactic Manual RotatIon in the Second stagE of Labor

NCT05175040 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-03-26

No results posted yet for this study

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.

Conditions

  • Labor Complication
  • Pregnancy Related

Interventions

PROCEDURE

Prophylactic manual rotation

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.

PROCEDURE

Sham rotation

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.

Sponsors & Collaborators

Principal Investigators

  • Stephanie Fisher, MD MPH · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-04
Primary Completion
2023-12-15
Completion
2023-12-15

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05175040 on ClinicalTrials.gov