Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID05881629

Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery: A Randomized Controlled Trial

Led by Women and Infants Hospital of Rhode Island · Updated on 2025-09-11

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether changing a laboring woman's position can increase the chances of delivering her baby vaginally, especially when the baby is facing upwards (occiput posterior) or sideways (occiput transverse). This randomized trial aims to determine if adopting a side-lying position with a peanut ball during active labor improves the likelihood of a spontaneous vaginal delivery and affects the baby's position at birth. The study also explores how these position changes influence the patient's sense of control during labor. Participants will be randomly assigned to one of two groups: one group will be asked to lie on their side on the same side as the baby's spine with a peanut ball placed between their legs for 60 minutes, while the other group will be allowed to choose any position without using a peanut ball during the same period. Ultrasound will be used during labor to confirm the baby's position and monitor any changes. The study focuses on women in active labor with specific fetal positions and cervical dilation between 6 and 9 centimeters. During the study, participants will receive ultrasounds to check the baby's position and will complete a questionnaire about their labor experience after delivery. Researchers will measure outcomes such as the rate of operative delivery (cesarean or assisted vaginal delivery), rotation of the baby to an optimal position, duration of labor stages, blood loss, degree of tearing, newborn health scores, and admission to neonatal intensive care. The total observation from enrollment through delivery is about 12 hours, with some follow-up assessments up to six weeks postpartum.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Maternal age >18 years
  • Term pregnancy (more than 37 weeks gestation)
  • Single baby pregnancy
  • In active labor with cervical dilation between 6 and 9 centimeters
  • Using epidural anesthesia
  • Baby's head down with occiput posterior or transverse position confirmed by bedside ultrasound
  • Continuous external fetal monitoring
  • Ability to give informed consent
Not Eligible

You will not qualify if you...

  • Multiple pregnancies
  • Labor without anesthesia
  • Known fetal abnormalities
  • Known fetal death before birth
  • Inability to provide informed consent

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 60 minutes

Participants in active labor with fetal malposition are randomized to adopt either a side-lying lateral position with a peanut ball or a free maternal position for 60 minutes.

1 in-person visit during active labor

Follow-up

Duration - Up to 6 weeks postpartum

Participants and their newborns are observed for outcomes related to delivery, recovery, and neonatal health.

Approximately 3 post-delivery visits including hospital discharge and neonatal care assessments

Trial Site Locations

Total: 1 location

1

Women and Infant's Hospital of Rhode Island

Providence, Rhode Island, United States, 02905

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Research Team

K

Kathryn M Anderson, MD

A

Alexis Gimovsky, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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