Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery
NCT ID: NCT05881629
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-05-01
2026-09-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Term gestation (\>37 weeks)
* Singleton pregnancy
* Spontaneous or induced active labor (cervical dilation 6-9cm)
* Epidural anesthesia
* Cephalic fetal presentation, OP/OT position diagnosed by bedside ultrasound
* Continuous external fetal monitoring
* Ability to consent
Exclusion Criteria
* Unanesthetized labor
* Known fetal anomalies
* Known intrauterine fetal demise
* Inability to consent
18 Years
FEMALE
Yes
Sponsors
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Women and Infants Hospital of Rhode Island
OTHER
Responsible Party
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Kathryn Anderson
Resident physician
Principal Investigators
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Alexis Gimovsky, MD
Role: PRINCIPAL_INVESTIGATOR
Women and Infant's Hospital of Rhode Island
Locations
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Women and Infant's Hospital of Rhode Island
Providence, Rhode Island, United States
Countries
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Central Contacts
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Other Identifiers
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2015598-1
Identifier Type: -
Identifier Source: org_study_id
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