NCT05881629

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Cesarean Delivery Affecting Fetus
• Labor Dystocia
• Labor Complication

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2023-05-31
• Last updated: 2025-09-11

Locations

1 site across 1 country: United States