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Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

Primary Purpose

Obstetric Labor Complications, Obstetric Trauma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Visual Biofeedback using self operated home ultrasound device
Visual Biofeedback using ultrasound at hospital
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obstetric Labor Complications focused on measuring Visual Biofeedback, Self Operated Ultrasound device, Second stage of labor, Trans Perineal Ultrasound

Eligibility Criteria

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

Inclusion Criteria: Nuliparity Singleton pregnancy Planned for vaginal delivery Low risk pregnancy Ability to fulfill a questionnaire Exclusion Criteria: Multifetal gestation Contraindications for vaginal delivery (Placenta previa, Breech presentation etc.) High risk pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Visual Biofeedback using self operated home ultrasound device

    Visual biofeedback at the Hospital

    Control / Standard care - Obstetrical ultrasound only

    Arm Description

    Sonographic fetal weight and biophysical profiles will be done at the hospital clinic. A single ultrasound biofeedback session using trans-perineal Ultrasound (TPU) will guide maternal pushing. The process includes (a) Ultrasound assessing fetal head descent with the screen facing the provider, measuring the angle of progression (AOP); (b) Explaining anatomical landmarks to the patient; (c) Repeat AOP measurement with the screen facing the patient for biofeedback; (d) Reassess with the screen turned away. Participants will receive a handheld home ultrasound device, learning to perform self-biofeedback at home, ideally twice a week, up to 4 times. Session records will be sent electronically to the sonographer for assessment and feedback. All groups will complete questionnaires three times: (1) baseline, (2) about two weeks later (after home biofeedback training), and (3) six to eight weeks postpartum.

    A sonographic fetal weight estimate and biophysical profile will occur at the hospital clinic for all patients. A single ultrasound-based biofeedback session will employ TPU for maternal pushing guidance. This process involves (a) Assessing fetal head descent with ultrasound to measure the angle of progression (AOP) during rest and pushing; (b) Explaining anatomical landmarks to the patient; (c) Repeating the AOP measurement as biofeedback; (d) Reassessing with the screen turned away. Participants will complete questionnaires three times: (1) baseline, (2) two weeks later, and (3) six to eight weeks postpartum.

    A sonographic estimated fetal weight and biophysical profile will be performed in the hospital. The participant will fill in questionnaires at three time points: (1) at baseline, before the ultrasound examination; (2) about two weeks later (i.e., after completing the self-operated visual biofeedback training at home, or at an equivalent time for the other two groups); (3) six to eight weeks postpartum.

    Outcomes

    Primary Outcome Measures

    The length of the second stage of labour
    Length of second stage of labor in minutes according to data retrieved from computerised medical file

    Secondary Outcome Measures

    Mode of delivery
    Spontaneous vaginal delivery or assisted operative delivery according to data retrieved from computerised medical file
    OASIS - obstetrical anal sphincter injuries
    according to data retrieved from computerised medical file
    Low neonatal APGAR score
    according to data retrieved from computerised medical file
    NICU (neonatal intensive care unit) hospitalization
    according to data retrieved from computerised medical file
    Fear of childbirth
    according to questionaires
    Anticipated self-control over various aspects of childbirth
    according to questionaires
    PTSS (post traumatic tree symptoms)
    according to questionaires

    Full Information

    First Posted
    September 1, 2023
    Last Updated
    September 17, 2023
    Sponsor
    Rabin Medical Center
    Collaborators
    Tel Aviv University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06049784
    Brief Title
    Prelabor Visual Biofeedback by a Self-operated Ultrasound Device
    Official Title
    Prelabor Maternal Pushing Training Using Visual Biofeedback by a Self-operated Ultrasound Device
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rabin Medical Center
    Collaborators
    Tel Aviv University

    4. Oversight

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

    5. Study Description

    Brief Summary
    A substantial number of women report fear of childbirth and negative birth experiences. Our objective is to assess the efficacy of visual biofeedback before labor by self-operated home ultrasound for maternal pushing training, which is expected to reduce fear of childbirth, increase perceived control during birth, prevent prolonged labor and the ensuing maternal and neonatal negative adverse outcomes, and prevent maternal post-traumatic stress symptoms. Intrapartum visual biofeedback provided by obstetricians during the second stage of labor has been shown to increase pushing efficiency and improve maternal obstetric and psychological outcomes. Visual biofeedback has been performed only in an in-hospital setting and, with one exception we are aware of, only during labor. A Mobile Self-Operated Home Ultrasound System was reported as a feasible and reliable tool for obstetrical ultrasound. A randomized controlled trial will be conducted with three study groups of pregnant women (37-39 weeks of gestation): (1) Obstetrical ultrasound+visual biofeedback in-hospital and at home using self-operated ultrasound; (1) Obstetrical ultrasound+visual biofeedback in-hospital; (3) Obstetrical ultrasound only. Visual biofeedback by ultrasound will be performed by transperineal ultrasound, enabling the future mother to visualize the descent of the fetal head within the birth canal in response to her pushing effort. Follow-up will be conducted two weeks later and at six weeks postpartum. Positive results following the application of biofeedback by self-operated home ultrasound may change the paradigm for pre-labour sonographic education. Self-operated home ultrasound will also enable more comprehensive pre-labor ultrasound-based education and hopefully reduce adverse physical and psychological outcomes following childbirth.
    Detailed Description
    The main objective of the present study is to assess the efficacy of visual biofeedback before labor by combining a single in-hospital session with a self-operated home ultrasound to train maternal pushing during the second stage of labor. The study combines the advantage of pre-labor training women in a single session at the clinic, as studied previously (Youssef et al., 2021), with an extended intervention and self-performed procedure at home over two weeks. This intervention is expected to augment the advantages previously described in the literature. The proposed study will assess the advantages of this intervention during training, followed by collecting detailed information on obstetric and psychological outcomes from medical records and using self-report questionnaires filled in by the participants before birth and postpartum. This intervention aims to prevent maternal and neonatal obstetric complications and adverse outcomes. Specifically, we aim: to shorten the length of the second stage, reduce the number of medical interventions during labor, and reduce complications during birth; to reduce prenatal fear of childbirth and increase confidence in the ability to give birth; to increase perceived personal control during labor and birth satisfaction; to improve maternal-infant bonding and reduce the rate of post-traumatic stress symptoms. to understand women's experience of the self-operated at-home intervention and its contribution through semi-structured in-depth interviews with a subsample of the women who participated in this study condition.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstetric Labor Complications, Obstetric Trauma
    Keywords
    Visual Biofeedback, Self Operated Ultrasound device, Second stage of labor, Trans Perineal Ultrasound

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Study design: A randomized controlled trial will be conducted at a single medical center. Intervention: Visual biofeedback by ultrasound will be performed by transperineal Ultrasound (TPU), enabling the future mother to visualize the descent of the fetal head within the birth canal in response to her pushing effort. Arms: (1) Home and hospital Intervention - Obstetrical ultrasound + visual biofeedback at the clinic and home using self-operated TPU. (2) Hospital intervention - Obstetrical ultrasound + visual biofeedback at the clinic (only one session in hospital). (3) Control / Standard care - Obstetrical ultrasound only. Arms 1 and 2, compared to 3, will support the efficacy of pre-labor training with visual biofeedback. Arm 1 versus 2 will support the added value of supplementing the in-hospital training with several additional sessions at home.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    261 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Visual Biofeedback using self operated home ultrasound device
    Arm Type
    Experimental
    Arm Description
    Sonographic fetal weight and biophysical profiles will be done at the hospital clinic. A single ultrasound biofeedback session using trans-perineal Ultrasound (TPU) will guide maternal pushing. The process includes (a) Ultrasound assessing fetal head descent with the screen facing the provider, measuring the angle of progression (AOP); (b) Explaining anatomical landmarks to the patient; (c) Repeat AOP measurement with the screen facing the patient for biofeedback; (d) Reassess with the screen turned away. Participants will receive a handheld home ultrasound device, learning to perform self-biofeedback at home, ideally twice a week, up to 4 times. Session records will be sent electronically to the sonographer for assessment and feedback. All groups will complete questionnaires three times: (1) baseline, (2) about two weeks later (after home biofeedback training), and (3) six to eight weeks postpartum.
    Arm Title
    Visual biofeedback at the Hospital
    Arm Type
    Active Comparator
    Arm Description
    A sonographic fetal weight estimate and biophysical profile will occur at the hospital clinic for all patients. A single ultrasound-based biofeedback session will employ TPU for maternal pushing guidance. This process involves (a) Assessing fetal head descent with ultrasound to measure the angle of progression (AOP) during rest and pushing; (b) Explaining anatomical landmarks to the patient; (c) Repeating the AOP measurement as biofeedback; (d) Reassessing with the screen turned away. Participants will complete questionnaires three times: (1) baseline, (2) two weeks later, and (3) six to eight weeks postpartum.
    Arm Title
    Control / Standard care - Obstetrical ultrasound only
    Arm Type
    No Intervention
    Arm Description
    A sonographic estimated fetal weight and biophysical profile will be performed in the hospital. The participant will fill in questionnaires at three time points: (1) at baseline, before the ultrasound examination; (2) about two weeks later (i.e., after completing the self-operated visual biofeedback training at home, or at an equivalent time for the other two groups); (3) six to eight weeks postpartum.
    Intervention Type
    Device
    Intervention Name(s)
    Visual Biofeedback using self operated home ultrasound device
    Intervention Description
    participants will receive a handheld home ultrasound device, learning to perform self-biofeedback at home. Session records will be sent electronically to the sonographer for assessment and feedback.
    Intervention Type
    Device
    Intervention Name(s)
    Visual Biofeedback using ultrasound at hospital
    Intervention Description
    A single ultrasound biofeedback session using Transperineal Ultrasound will guide maternal pushing.
    Primary Outcome Measure Information:
    Title
    The length of the second stage of labour
    Description
    Length of second stage of labor in minutes according to data retrieved from computerised medical file
    Time Frame
    through study completion, an average of 6 months
    Secondary Outcome Measure Information:
    Title
    Mode of delivery
    Description
    Spontaneous vaginal delivery or assisted operative delivery according to data retrieved from computerised medical file
    Time Frame
    through study completion, an average of 6 months
    Title
    OASIS - obstetrical anal sphincter injuries
    Description
    according to data retrieved from computerised medical file
    Time Frame
    through study completion, an average of 6 months
    Title
    Low neonatal APGAR score
    Description
    according to data retrieved from computerised medical file
    Time Frame
    through study completion, an average of 6 months
    Title
    NICU (neonatal intensive care unit) hospitalization
    Description
    according to data retrieved from computerised medical file
    Time Frame
    through study completion, an average of 6 months
    Title
    Fear of childbirth
    Description
    according to questionaires
    Time Frame
    through study completion, an average of 6 months
    Title
    Anticipated self-control over various aspects of childbirth
    Description
    according to questionaires
    Time Frame
    through study completion, an average of 6 months
    Title
    PTSS (post traumatic tree symptoms)
    Description
    according to questionaires
    Time Frame
    through study completion, an average of 6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Nuliparity Singleton pregnancy Planned for vaginal delivery Low risk pregnancy Ability to fulfill a questionnaire Exclusion Criteria: Multifetal gestation Contraindications for vaginal delivery (Placenta previa, Breech presentation etc.) High risk pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shira Waks
    Phone
    972528557212
    Email
    Shiraw@clalit.org.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sharon Perlman, MD
    Phone
    972547481097
    Email
    drsharonperlman@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sharon Perlman, MD
    Organizational Affiliation
    Rabin Medical Center, affiliated to the Tel Aviv University, Tel Aviv, Israel
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    All collected data will be securely stored and used solely for research, analysis, and reporting within the scope of this study. Any results or findings that we may share with the scientific community or the public will be presented in aggregated, de-identified, and anonymized formats to protect participant privacy. Our primary focus is to use the gathered data for research purposes, and we do not anticipate sharing individual participant data beyond the confines of this study's objectives.
    Citations:
    PubMed Identifier
    29155474
    Citation
    Gilboa Y, Frenkel TI, Schlesinger Y, Rousseau S, Hamiel D, Achiron R, Perlman S. Visual biofeedback using transperineal ultrasound in second stage of labor. Ultrasound Obstet Gynecol. 2018 Jul;52(1):91-96. doi: 10.1002/uog.18962. Epub 2018 May 29.
    Results Reference
    background
    PubMed Identifier
    29532533
    Citation
    Bellussi F, Alcamisi L, Guizzardi G, Parma D, Pilu G. Traditionally vs sonographically coached pushing in second stage of labor: a pilot randomized controlled trial. Ultrasound Obstet Gynecol. 2018 Jul;52(1):87-90. doi: 10.1002/uog.19044. Epub 2018 May 30.
    Results Reference
    background
    PubMed Identifier
    33729014
    Citation
    Hadar E, Wolff L, Tenenbaum-Gavish K, Eisner M, Shmueli A, Barbash-Hazan S, Bergel R, Shmuel E, Houri O, Dollinger S, Brzezinski-Sinai NA, Sukenik S, Pardo A, Navon I, Wilk Y, Zafrir-Danieli H, Wiznitzer A. Mobile Self-Operated Home Ultrasound System for Remote Fetal Assessment During Pregnancy. Telemed J E Health. 2022 Jan;28(1):93-101. doi: 10.1089/tmj.2020.0541. Epub 2021 Mar 15.
    Results Reference
    background
    PubMed Identifier
    32105133
    Citation
    Schlesinger Y, Hamiel D, Rousseau S, Perlman S, Gilboa Y, Achiron R, Frenkel TI. Preventing risk for posttraumatic stress following childbirth: Visual biofeedback during childbirth increases maternal connectedness to her newborn thereby preventing risk for posttraumatic stress following childbirth. Psychol Trauma. 2022 Sep;14(6):1057-1065. doi: 10.1037/tra0000558. Epub 2020 Feb 27.
    Results Reference
    background

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    Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

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