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Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery

Primary Purpose

Cesarean Delivery Affecting Fetus, Labor Dystocia, Labor Complication

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Maternal position change to side-lying lateral with peanut ball
Free maternal position
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Delivery Affecting Fetus focused on measuring fetal malposition, occiput posterior, occiput transverse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Side-lying peanut ball group

    Control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Operative Delivery Rate
    The combined rate of cesarean and instrumental vaginal deliveries in each study group

    Secondary Outcome Measures

    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
    Rotation at Delivery
    The percent of fetuses that rotate to facing downwards (occiput anterior, OA) at the time of delivery in each study group
    Duration of Active Second Stage
    The mean amount of time spent pushing during the second stage of labor in each group (measured in minutes)
    Estimated Blood Loss
    The mean amount of blood loss incurred at delivery in each study group (measured in mL)
    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
    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).
    Apgar Scores
    Mean Apgar Score at 1 and 5 minutes for fetuses delivered in each study group
    Neonatal Intensive Care Unit (NICU) Admission
    Rates of NICU admission following delivery in each study group

    Full Information

    First Posted
    May 18, 2023
    Last Updated
    May 28, 2023
    Sponsor
    Women and Infants Hospital of Rhode Island
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05881629
    Brief Title
    Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery
    Official Title
    Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2025 (Anticipated)
    Study Completion Date
    June 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Women and Infants Hospital of Rhode Island

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cesarean Delivery Affecting Fetus, Labor Dystocia, Labor Complication
    Keywords
    fetal malposition, occiput posterior, occiput transverse

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Intervention group (side-lying position with peanut ball) versus control group (free position choice, no peanut ball)
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Side-lying peanut ball group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Maternal position change to side-lying lateral with peanut ball
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Free maternal position
    Intervention Description
    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 Measure Information:
    Title
    Operative Delivery Rate
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Rotation at Complete Dilation
    Description
    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
    Title
    Rotation at Delivery
    Description
    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
    Title
    Duration of Active Second Stage
    Description
    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
    Title
    Estimated Blood Loss
    Description
    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
    Title
    Degree of Laceration following Delivery
    Description
    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
    Title
    Score on Labor Agentry Scale
    Description
    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
    Title
    Apgar Scores
    Description
    Mean Apgar Score at 1 and 5 minutes for fetuses delivered in each study group
    Time Frame
    Time of delivery to 5 minutes postpartum
    Title
    Neonatal Intensive Care Unit (NICU) Admission
    Description
    Rates of NICU admission following delivery in each study group
    Time Frame
    Time of delivery to up to 6 weeks postpartum

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kathryn M Anderson, MD
    Phone
    401-274-1100
    Email
    kathryn.anderson24@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexis Gimovsky, MD
    Email
    agimovsky@kentri.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexis Gimovsky, MD
    Organizational Affiliation
    Women and Infant's Hospital of Rhode Island
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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