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

Women and Infants Hospital of Rhode Island

Status: Enrolling

Conditions: Labor Dystocia; Cesarean Delivery Affecting Fetus; Labor Complication

Treatments: Behavioral: Free maternal position; Behavioral: Maternal position change to side-lying lateral with peanut ball

Study type: Interventional

Funder types: Other

Identifiers

NCT05881629

2015598-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

Side-lying peanut ball group

Experimental group

Description:

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.

Treatment:

Behavioral: Maternal position change to side-lying lateral with peanut ball

Control group

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Free maternal position