Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Maternal position change to side-lying lateral with peanut ball, Free maternal position.
- Who it may be relevant to
- Registry conditions: Cesarean Delivery Affecting Fetus, Labor Dystocia, Labor Complication. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery: A Randomized Controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Operative Delivery Rate [Time frame: Enrollment in active labor through delivery, on average 12 hours]
Secondary outcome measures (8)
- Rotation at Complete Dilation [Time frame: Enrollment in active labor through delivery, on average 12 hours]
- Rotation at Delivery [Time frame: Enrollment in active labor through delivery, on average 12 hours]
- Duration of Active Second Stage [Time frame: Onset of second stage of labor to delivery, up to 4 hours]
- Estimated Blood Loss [Time frame: Time of delivery to 24 hours postpartum]
- Degree of Laceration following Delivery [Time frame: Time of delivery to admission to postpartum unit, on average 2 hours]
- Score on Labor Agentry Scale [Time frame: Time of delivery to discharge from hospital, on average 2 days]
- Apgar Scores [Time frame: Time of delivery to 5 minutes postpartum]
- Neonatal Intensive Care Unit (NICU) Admission [Time frame: Time of delivery to up to 6 weeks postpartum]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Women and Infant's Hospital of Rhode Island — Providence
Identifiers
NCT: NCT05881629 · 2015598-1