Recruiting

Position Change

Sponsor:

Women and Infants Hospital of Rhode Island

Code:

NCT05881629

Conditions

Cesarean Delivery Affecting Fetus

Labor Dystocia

Labor Complication

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Maternal position change to side-lying lateral with peanut ball

Free maternal position

Study Details

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

Cesarean Delivery Affecting Fetus

Labor Dystocia

Labor Complication

Study ID

NCT05881629

Start date

May 1, 2024

Status verified date

Sep, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kathryn M Anderson, MD

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

Alexis Gimovsky, MD

agimovsky@kentri.org

Locations

Women and Infant's Hospital of Rhode Island

Recruiting

Providence, Rhode Island, United States, 02905

More Information

Sponsor

Women and Infants Hospital of Rhode Island

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Keywords

  • fetal malposition
  • occiput posterior
  • occiput transverse

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island on 2025-09-11.