Early ultrasound and side-lying position with a peanut ball for babies facing up or sideways during labor
Official title: Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery: A Randomized Controlled Trial
Run by Women and Infants Hospital of Rhode Island · NCT05881629 · Data updated 2026-11-12
This trial tests whether asking people in active labor whose babies are occiput posterior or occiput transverse to lie on their side with a peanut ball helps them have a spontaneous vaginal delivery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Women and Infants Hospital of Rhode Island Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Status | Recruiting |
| Started | May 1, 2024 |
| Main results expected | September 1, 2026 |
| Study ends | September 1, 2026 |
| Registry record updated | September 11, 2025 |
| Trial ID | NCT05881629 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (>18 years) at term (>37 weeks) with a single, cephalic pregnancy in active labor (6–9 cm) with epidural analgesia and ultrasound-confirmed occiput posterior or transverse fetal position are the intended participants.
✕Probably not a fit
People without OP/OT fetal positions, those with multiple pregnancies, known fetal anomalies, intrauterine fetal demise, no epidural, inability to consent, or who cannot be at the study site are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized trial, people in active labor (>6 cm dilation) who have a baby diagnosed by bedside ultrasound as occiput posterior (OP) or occiput transverse (OT) will be assigned to either a side-lying (modified Sims) position ipsilateral to the fetal spine with a peanut ball or to free maternal position choice. All participants will receive ultrasound confirmation of fetal position during labor and additional ultrasounds to document any rotations toward occiput anterior (OA) at full dilation and at delivery. The primary outcome is operative delivery rate (cesarean or instrument-assisted vaginal delivery), and secondary outcomes include rates of spontaneous fetal rotation and patient-reported labor experience and perceived autonomy. The protocol is limited to term, singleton, cephalic pregnancies with epidural analgesia and continuous external fetal monitoring.
Why it matters
Potential benefit: If successful, this approach could increase the chance of spontaneous vaginal birth and reduce cesarean or instrumented deliveries for people with OP/OT fetal positions.
How similar studies have gone: Smaller trials and observational studies have suggested positional changes and peanut-ball use can help labor progress in some settings, but high-quality randomized evidence specifically for OP/OT fetuses is limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Women and Infant's Hospital of Rhode Island
Providence, Rhode Island, United States Recruiting
Study contacts
- Principal investigator: Alexis Gimovsky, MD — Women and Infant's Hospital of Rhode Island
- Study coordinator: Kathryn M Anderson, MD
- Email: kathryn.anderson24@gmail.com
- Phone: 401-274-1100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.