NCT05881629 · Women and Infants Hospital of Rhode Island
Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery
What this study is about
The goal of this randomly assigned trial is to test if changing a person's position in labor can increase the chances of delivering their baby vaginally.
View original scientific description
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.
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
The combined rate of cesarean and instrumental vaginal deliveries in each study group
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Providence, Rhode Island
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 11, 2025 · Source of record for eligibility and locations