Early ultrasound and side-lying position with a peanut ball for babies facing up or sideways during labor
Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Women and Infants Hospital of Rhode Island Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT05881629 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Providence, Rhode Island
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.