An interventional study of Maternal position change to side-lying lateral with peanut ball and Free maternal position in Cesarean Delivery Affecting Fetus, Labor Dystocia and Labor Complication, sponsored by Women and Infants Hospital of Rhode Island. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Women and Infants Hospital of Rhode Island · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →Women and Infants Hospital of Rhode Island is the lead sponsor of 93 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants randomized to this group will be asked to adopt a side-lying, lateral position on the ipsilateral side of the fetal spine. A peanut ball will be positioned between the participant's legs while in this position. They will be asked to maintain this position for 60 minutes.
Behavioral: Maternal position change to side-lying lateral with peanut ball
Participants randomized to this group will be able to adopt any position of their choosing during the 60-minute study period. They will not be able to use a peanut ball during this time.
Behavioral: Free maternal position
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.
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.
Operative Delivery Rate
The combined rate of cesarean and instrumental vaginal deliveries in each study group
Time frame: Enrollment in active labor through delivery, on average 12 hours
Rotation at Complete Dilation
The percent of fetuses that rotate to facing downwards (occiput anterior) at the time of complete cervical dilation (10cm) in each study group
Time frame: Enrollment in active labor through delivery, on average 12 hours
Rotation at Delivery
The percent of fetuses that rotate to facing downwards (occiput anterior, OA) at the time of delivery in each study group
Time frame: Enrollment in active labor through delivery, on average 12 hours
Duration of Active Second Stage
The mean amount of time spent pushing during the second stage of labor in each group (measured in minutes)
Time frame: Onset of second stage of labor to delivery, up to 4 hours
Estimated Blood Loss
The mean amount of blood loss incurred at delivery in each study group (measured in mL)
Time frame: Time of delivery to 24 hours postpartum
Degree of Laceration following Delivery
The percent of each degree of vaginal laceration (first, second, third, fourth) sustained during vaginal delivery in each study group
Time frame: Time of delivery to admission to postpartum unit, on average 2 hours
Score on Labor Agentry Scale
The mean score on the validated Labor Agentry Scale (LAS) in each study group, which measures the degree that the participant felt in control during their labor process. Possible total scores for the Labor Agentry Scale range from 10 (rarely felt in control) to 70 (almost always felt in control).
Time frame: Time of delivery to discharge from hospital, on average 2 days
Apgar Scores
Mean Apgar Score at 1 and 5 minutes for fetuses delivered in each study group
Time frame: Time of delivery to 5 minutes postpartum
Neonatal Intensive Care Unit (NICU) Admission
Rates of NICU admission following delivery in each study group
Time frame: Time of delivery to up to 6 weeks postpartum
Plan to share: No
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Women and Infants Hospital of Rhode Island