NCT05881629 Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery
| NCT ID | NCT05881629 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Women and Infants Hospital of Rhode Island |
| Condition | Cesarean Delivery Affecting Fetus |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-05-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Alexis Gimovsky, MD
PRINCIPAL INVESTIGATOR
Women and Infant's Hospital of Rhode Island
Frequently Asked Questions
Who can join the NCT05881629 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cesarean Delivery Affecting Fetus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05881629 currently recruiting?
Yes, NCT05881629 is actively recruiting participants. Contact the research team at kathryn.anderson24@gmail.com for enrollment information.
Where is the NCT05881629 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT05881629 clinical trial?
NCT05881629 is sponsored by Women and Infants Hospital of Rhode Island. The principal investigator is Alexis Gimovsky, MD at Women and Infant's Hospital of Rhode Island. The trial plans to enroll 200 participants.