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NCT Number: NCT05881629

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

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

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Key information

Conditions

Cesarean Delivery Affecting Fetus Dystocia Female Urogenital Diseases and Pregnancy Complications Labor Complication Labor Dystocia Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women and Infant's Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Operative Delivery Rate

    Time frame: Enrollment in active labor through delivery, on average 12 hours

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

Secondary outcomes

  1. Rotation at Complete Dilation

    Time frame: Enrollment in active labor through delivery, on average 12 hours

    The percent of fetuses that rotate to facing downwards (occiput anterior) at the time of complete cervical dilation (10cm) in each study group

  2. Rotation at Delivery

    Time frame: Enrollment in active labor through delivery, on average 12 hours

    The percent of fetuses that rotate to facing downwards (occiput anterior, OA) at the time of delivery in each study group

  3. Duration of Active Second Stage

    Time frame: Onset of second stage of labor to delivery, up to 4 hours

    The mean amount of time spent pushing during the second stage of labor in each group (measured in minutes)

  4. Estimated Blood Loss

    Time frame: Time of delivery to 24 hours postpartum

    The mean amount of blood loss incurred at delivery in each study group (measured in mL)

  5. Degree of Laceration following Delivery

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

    The percent of each degree of vaginal laceration (first, second, third, fourth) sustained during vaginal delivery in each study group

  6. Score on Labor Agentry Scale

    Time frame: Time of delivery to discharge from hospital, on average 2 days

    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).

  7. Apgar Scores

    Time frame: Time of delivery to 5 minutes postpartum

    Mean Apgar Score at 1 and 5 minutes for fetuses delivered in each study group

  8. Neonatal Intensive Care Unit (NICU) Admission

    Time frame: Time of delivery to up to 6 weeks postpartum

    Rates of NICU admission following delivery in each study group

Study contacts

Contact information is provided by the study sponsor or research team.

Alexis Gimovsky, MD

CONTACT

[email protected]

Kathryn M Anderson, MD

CONTACT

[email protected]

401-274-1100

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 31, 2023
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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