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Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery

NCT05881629 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-09-11

No results posted yet for this study

Summary

The goal of this randomized trial is to test if changing a person's position in labor can increase the chances of delivering their baby vaginally.

Specifically, it aims to answer the questions:

* In fetuses who are facing upwards (occiput posterior, OP) or sideways (occiput transverse, OT) during labor, does changing the patient's position during active labor to a side-lying posture with a peanut ball increase the chances of them having a successful, spontaneous vaginal delivery?
* Does changing the patient's position in active labor affect the position of the baby at the time of delivery?
* Do intentional position changes in labor impact patient-perceived autonomy during their labor and delivery experience?

Participants will:

* Receive an ultrasound during labor to determine the position of their baby
* Be asked to adopt a specific position in labor (side-lying with peanut ball) if they are randomized to the study group
* Receive additional ultrasounds during labor to assess their baby's position
* Fill out a questionnaire about their labor experience following the delivery of their baby

Conditions

  • Cesarean Delivery Affecting Fetus
  • Labor Dystocia
  • Labor Complication

Interventions

BEHAVIORAL

Maternal position change to side-lying lateral with peanut ball

Participants will be assisted into a position lying on their side, specifically the same side as the fetal spine diagnosed by ultrasound. An inflated peanut ball will be positioned between the legs to open the pelvis. They will be asked to maintain the position for 60 minutes.

BEHAVIORAL

Free maternal position

Participants will be asked to adopt any position of their choosing and to maintain it for 60 minutes. They will be asked to not use a peanut ball during the 60 minute study period.

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Alexis Gimovsky, MD · Women and Infant's Hospital of Rhode Island

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2026-09-01
Completion
2026-09-01

Countries

  • United States

Study Locations

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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 NCT05881629 on ClinicalTrials.gov