Cesarean Delivery Affecting FetusNCT05881629
Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery
A study testing Maternal position change to side-lying lateral with peanut ball and Free maternal position in people with Cesarean Delivery Affecting Fetus and Labor Dystocia, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Delivery Affecting Fetus, Labor Dystocia, Labor Complication
- What is being tested?
- Maternal position change to side-lying lateral with peanut ball and Free maternal position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Multiple gestations
- Unanesthetized labor
- Known fetal anomalies
- Known intrauterine fetal demise
- Inability to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alexis Gimovsky, MD contact
United States1 site, 1 recruiting
- Recruiting
Women and Infant's Hospital of Rhode Island
Providence, Rhode Island, 02905
About this study
Official title: Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery: A Randomized Controlled Trial
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:
Read more
- 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
Read the detailed description
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.
- Being tested
- Maternal position change to side-lying lateral with peanut ball, Free maternal position
- Keywords
- fetal malposition, occiput posterior, occiput transverse
- Medical subject headings
- Dystocia, Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal position change to side-lying lateral with peanut ballBehavioural
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.
Free maternal positionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Side-lying peanut ball group | Experimental | 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. Receives: Behavioral: Maternal position change to side-lying lateral with peanut ball |
| Control group | Placebo comparator | 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. Receives: Behavioral: Free maternal position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Delivery Rate
The combined rate of cesarean and instrumental vaginal deliveries in each study group
Measured: Enrollment in active labor through delivery, on average 12 hours
Secondary outcomes (8)
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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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).
Measured: 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
Measured: Time of delivery to 5 minutes postpartum
Neonatal Intensive Care Unit (NICU) Admission
Rates of NICU admission following delivery in each study group
Measured: Time of delivery to up to 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 May 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Delivery Affecting FetusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group (side-lying position with peanut ball) versus control group (free position choice, no peanut ball)
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Anderson, Women and Infants Hospital of Rhode Island
- Investigators
- Alexis Gimovsky, MD, Principal investigator, Women and Infant's Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881629
- Sponsor's protocol ID
- 2015598-1
- Status last verified
- Sep 2025
- First submitted
- 18 May 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05881629
- Acronym / sponsor ID
- 2015598-1
- Keywords
- fetal malposition, occiput posterior, occiput transverse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group (side-lying position with peanut ball) versus control group (free position choice, no peanut ball)
| Arm | Type | Receives |
|---|---|---|
| Side-lying peanut ball group | Experimental | Behavioral: Maternal position change to side-lying lateral with peanut ballParticipants 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. |
| Control group | Placebo comparator | Behavioral: Free maternal positionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Maternal age >18
- Term gestation (>37 weeks)
- Singleton pregnancy
- Spontaneous or induced active labor (cervical dilation 6-9cm)
- Epidural anesthesia
Key exclusion criteria (5 listed)
- Multiple gestations
- Unanesthetized labor
- Known fetal anomalies
- Known intrauterine fetal demise
- Inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal position change to side-lying lateral with peanut ballParticipants 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. | Behavioural | Side-lying peanut ball group |
| Free maternal positionParticipants 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. | Behavioural | Control group |
Primary outcome
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
8 secondary outcomes
Rotation at Complete Dilation
Time frame: Enrollment in active labor through delivery, on average 12 hours
Rotation at Delivery
Time frame: Enrollment in active labor through delivery, on average 12 hours
Duration of Active Second Stage
Time frame: Onset of second stage of labor to delivery, up to 4 hours
Estimated Blood Loss
Time frame: Time of delivery to 24 hours postpartum
Degree of Laceration following Delivery
Time frame: Time of delivery to admission to postpartum unit, on average 2 hours
Score on Labor Agentry Scale
Time frame: Time of delivery to discharge from hospital, on average 2 days
Apgar Scores
Time frame: Time of delivery to 5 minutes postpartum
Neonatal Intensive Care Unit (NICU) Admission
Time frame: Time of delivery to up to 6 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexis Gimovsky, MD contact
Alexis Gimovsky, MD principal investigator
Women and Infant's Hospital of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal position change to side-lying lateral with peanut ball and Free maternal position in people with Cesarean Delivery Affecting Fetus and Labor Dystocia, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathryn M Anderson, MD (401-274-1100, kathryn.anderson24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative Delivery Rate (time frame: Enrollment in active labor through delivery, on average 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.