RecruitingNot ApplicableNCT05881629

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


Sponsor

Women and Infants Hospital of Rhode Island

Enrollment

200 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an intervention to correct fetal malposition during active labor — specifically when the baby's head is in an occiput posterior (OP) or occiput transverse (OT) position, meaning the baby is facing forward (sunny-side up) or sideways instead of the ideal backward-facing position. Malposition is a major cause of prolonged, painful labor, failed vaginal delivery, and emergency cesarean sections. Detecting the position with bedside ultrasound and then using physical maneuvers to rotate the baby may reduce these complications. Eligible participants are women over 18 in term (37+ weeks) singleton pregnancies who are in active labor with cervical dilation of 6 to 9 cm, have epidural anesthesia, and have been diagnosed with OP or OT position by ultrasound. Multiple gestations, known fetal anomalies, fetal demise, and inability to consent are exclusion criteria. Participants are randomized to early detection and rotation intervention versus standard care, with the primary outcome being mode of delivery (vaginal versus cesarean). This trial addresses a high-stakes obstetric question — if rotation maneuvers guided by real-time ultrasound can prevent cesareans and reduce labor complications, the implications for maternal care globally would be substantial.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMaternal 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.

BEHAVIORALFree 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.


Locations(1)

Women and Infant's Hospital of Rhode Island

Providence, Rhode Island, United States

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NCT05881629


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