Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
Actively Recruiting
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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