Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery
- Conditions
- Cesarean Delivery Affecting FetusLabor DystociaLabor Complication
- Interventions
- Behavioral: Free maternal positionBehavioral: Maternal position change to side-lying lateral with peanut ball
- Registration Number
- NCT05881629
- Lead Sponsor
- Women and Infants Hospital of Rhode Island
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- 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
- Multiple gestations
- Unanesthetized labor
- Known fetal anomalies
- Known intrauterine fetal demise
- Inability to consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Free maternal position 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. Side-lying peanut ball group Maternal position change to side-lying lateral with peanut ball 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.
- Primary Outcome Measures
Name Time Method Operative Delivery Rate Enrollment in active labor through delivery, on average 12 hours The combined rate of cesarean and instrumental vaginal deliveries in each study group
- Secondary Outcome Measures
Name Time Method Estimated Blood Loss Time of delivery to 24 hours postpartum The mean amount of blood loss incurred at delivery in each study group (measured in mL)
Duration of Active Second Stage 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)
Score on Labor Agentry Scale 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).
Rotation at Complete Dilation 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
Rotation at Delivery 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
Apgar Scores Time of delivery to 5 minutes postpartum Mean Apgar Score at 1 and 5 minutes for fetuses delivered in each study group
Degree of Laceration following Delivery 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
Neonatal Intensive Care Unit (NICU) Admission Time of delivery to up to 6 weeks postpartum Rates of NICU admission following delivery in each study group