Clinical trial NCT05881629: Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery
Official title: Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cesarean Delivery Affecting Fetus
Labor Dystocia
Labor Complication
Keywords: fetal malposition
occiput posterior
occiput transverse
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group (side-lying position with peanut ball) versus control group (free position choice, no peanut ball)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Operative Delivery Rate
timeFrame: Enrollment in active labor through delivery, on average 12 hours
Secondary outcomes:
measure: Rotation at Complete Dilation
timeFrame: Enrollment in active labor through delivery, on average 12 hours
measure: Rotation at Delivery
timeFrame: Enrollment in active labor through delivery, on average 12 hours
measure: Duration of Active Second Stage
timeFrame: Onset of second stage of labor to delivery, up to 4 hours
measure: Estimated Blood Loss
timeFrame: Time of delivery to 24 hours postpartum
measure: Degree of Laceration following Delivery
timeFrame: Time of delivery to admission to postpartum unit, on average 2 hours
measure: Score on Labor Agentry Scale
timeFrame: Time of delivery to discharge from hospital, on average 2 days
measure: Apgar Scores
timeFrame: Time of delivery to 5 minutes postpartum
measure: Neonatal Intensive Care Unit (NICU) Admission
timeFrame: Time of delivery to up to 6 weeks postpartum
Other outcomes:
Locations:
Study officials:
affiliation: Women and Infant's Hospital of Rhode Island
name: Alexis Gimovsky, MD
role: PRINCIPAL_INVESTIGATOR
References: