Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cesarean Delivery Affecting Fetus
- Sponsor
- Women and Infants Hospital of Rhode Island
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Operative Delivery Rate
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief 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.
Investigators
Kathryn Anderson
Resident physician
Women and Infants Hospital of Rhode Island
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Estimated Blood Loss(Time of delivery to 24 hours postpartum)
- Duration of Active Second Stage(Onset of second stage of labor to delivery, up to 4 hours)
- Score on Labor Agentry Scale(Time of delivery to discharge from hospital, on average 2 days)
- Rotation at Complete Dilation(Enrollment in active labor through delivery, on average 12 hours)
- Rotation at Delivery(Enrollment in active labor through delivery, on average 12 hours)
- Apgar Scores(Time of delivery to 5 minutes postpartum)
- Degree of Laceration following Delivery(Time of delivery to admission to postpartum unit, on average 2 hours)
- Neonatal Intensive Care Unit (NICU) Admission(Time of delivery to up to 6 weeks postpartum)