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

Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery: A Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Labor Complication; Cesarean Delivery Affecting Fetus; Labor Dystocia
• Intervention / Treatment: Behavioral: Maternal position change to side-lying lateral with peanut ball; Behavioral: Free maternal position

Detailed Description

In this randomized trial, the investigators aim to evaluate the effects of early ultrasound diagnosis and active management of fetal malposition during the first stage of labor. Specifically, the investigators will compare the modified Sims (side-lying) position ipsilateral to fetal spine with the addition of a peanut ball versus free maternal position choice in occiput posterior (OP) or occiput transverse (OT) fetuses diagnosed by ultrasound during active labor, defined as greater than 6cm cervical dilation. The primary outcome will be operative delivery rates, defined as either cesarean delivery or instrumental vaginal delivery with vacuum or forceps. The investigators will also assess rates of spontaneous rotation to occiput anterior (OA) position at complete dilation and at delivery, as well as the impact of the position changes on the patient's labor experience and their perceived autonomy.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathryn M Anderson, MD; Phone Number: 401-274-1100; Email: kathryn.anderson24@gmail.com
• Study Contact Backup: Name: Alexis Gimovsky, MD; Email: agimovsky@kentri.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Recruiting
      • Women and Infant's Hospital of Rhode Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rotation at Complete Dilation	The percent of fetuses that rotate to facing downwards (occiput anterior) at the time of complete cervical dilation (10cm) in each study group	Enrollment in active labor through delivery, on average 12 hours
Rotation at Delivery	The percent of fetuses that rotate to facing downwards (occiput anterior, OA) at the time of delivery in each study group	Enrollment in active labor through delivery, on average 12 hours
Duration of Active Second Stage	The mean amount of time spent pushing during the second stage of labor in each group (measured in minutes)	Onset of second stage of labor to delivery, up to 4 hours
Estimated Blood Loss	The mean amount of blood loss incurred at delivery in each study group (measured in mL)	Time of delivery to 24 hours postpartum
Degree of Laceration following Delivery	The percent of each degree of vaginal laceration (first, second, third, fourth) sustained during vaginal delivery in each study group	Time of delivery to admission to postpartum unit, on average 2 hours
Score on Labor Agentry Scale	The mean score on the validated Labor Agentry Scale (LAS) in each study group, which measures the degree that the participant felt in control during their labor process. Possible total scores for the Labor Agentry Scale range from 10 (rarely felt in control) to 70 (almost always felt in control).	Time of delivery to discharge from hospital, on average 2 days
Apgar Scores	Mean Apgar Score at 1 and 5 minutes for fetuses delivered in each study group	Time of delivery to 5 minutes postpartum
Neonatal Intensive Care Unit (NICU) Admission	Rates of NICU admission following delivery in each study group	Time of delivery to up to 6 weeks postpartum

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Investigators: Principal Investigator: Alexis Gimovsky, MD, Women and Infant's Hospital of Rhode Island

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 28, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: fetal malposition; occiput posterior; occiput transverse
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Obstetric Labor Complications; Dystocia
• Other Study ID Numbers: 2015598-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No