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

NCT05881629 | Recruiting

• 1 other identifier: 2015598-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Labor Dystocia; Labor Complication; Cesarean Delivery Affecting Fetus

Keywords

fetal malposition; occiput posterior; occiput transverse

Outcome Measures

Primary Outcomes (1)

• Operative Delivery Rate

  The combined rate of cesarean and instrumental vaginal deliveries in each study group

  Enrollment in active labor through delivery, on average 12 hours

Secondary Outcomes (8)

• Rotation at Complete Dilation

  Enrollment in active labor through delivery, on average 12 hours

• Rotation at Delivery

  Enrollment in active labor through delivery, on average 12 hours

• Duration of Active Second Stage

  Onset of second stage of labor to delivery, up to 4 hours

• Estimated Blood Loss

  Time of delivery to 24 hours postpartum

• Degree of Laceration following Delivery

  Time of delivery to admission to postpartum unit, on average 2 hours

Study Arms (2)

Side-lying peanut ball group

EXPERIMENTAL

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.

Behavioral: Maternal position change to side-lying lateral with peanut ball

Control group

PLACEBO COMPARATOR

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.

Behavioral: Free maternal position

Interventions

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.

Control group

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.

Side-lying peanut ball group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maternal age \>18
• 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

You may not qualify if:

• Multiple gestations
• Unanesthetized labor
• Known fetal anomalies
• Known intrauterine fetal demise
• Inability to consent

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women and Infant's Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

RECRUITING

MeSH Terms

Conditions

Dystocia; Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Alexis Gimovsky, MD

  Women and Infant's Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn M Anderson, MD

CONTACT

401-274-1100; kathryn.anderson24@gmail.com

Alexis Gimovsky, MD

CONTACT

agimovsky@kentri.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Model Details: Intervention group (side-lying position with peanut ball) versus control group (free position choice, no peanut ball)

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 31, 2023
• Study Start: May 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)