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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Women and Infants Hospital of Rhode Island
Study ID
NCT05881629
Status
Recruiting
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Conditions

  • Cesarean Delivery Affecting Fetus
  • Labor Complication
  • Labor Dystocia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Maternal position change to side-lying lateral with peanut ball — BEHAVIORAL
    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.
  • Free maternal position — BEHAVIORAL
    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.

Study Details

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

Key Dates

Start date
May 1, 2024
Status verified
Sep 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Side-lying peanut ball group
    Participants randomized to this group will be asked to adopt a side-lying, lateral position on the ipsilateral side of the fetal spine. A peanut ball will be positioned between the participant's legs while in this position. They will be asked to maintain this position for 60 minutes.
  • Placebo Comparator: Control group
    Participants randomized to this group will be able to adopt any position of their choosing during the 60-minute study period. They will not be able to use a peanut ball during this time.

Primary Outcome Measure

Operative Delivery Rate [ Time Frame: Enrollment in active labor through delivery, on average 12 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Women and Infant's Hospital of Rhode IslandProvidenceRhode Island02905-

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By research site
Women and Infant's Hospital of Rhode Island· Providence, RI

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