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In Vivo Evaluation of Perineal Mechanical Properties During Childbirth (MecaPer)

Primary Purpose

Perineum; Rupture, Perineum; Tear, Perineal Tear

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
assessment in the 8th month of pregnancy and during delivery
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Perineum; Rupture focused on measuring perineal tear, hyperelasticity

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant and volunteer women >18 years old
  • Primiparous
  • With a singleton pregnancy
  • No objection from the subject and the spouse to participate in the study

Exclusion Criteria:

  • History of prior delivery or c-section
  • History of perineal troubles
  • BMI > à 35 mg/m²
  • History of chronic muscular disease or connective tissue pathology
  • Psychiatric pathology requiring hospitalization
  • Patients who do not understand the French language
  • Legal incapacity or limited legal capacity
  • Patients unlikely to cooperate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    assessment in the 8th month of pregnancy and during delivery

    Arm Description

    The study design includes a consultation during pregnancy between 36 and 38 weeks of gestation and an assessment in the delivery room during childbirth

    Outcomes

    Primary Outcome Measures

    maximum value of equivalent deformation obtained by stereovision camera
    maximum value of equivalent deformation obtained by stereovision camera

    Secondary Outcome Measures

    Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB
    Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB
    Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB
    elta between the minimum and maximum width of GH, and between the maximum and minimum length of PB
    Correlation between perineal deformation values and perineal tears
    Correlation between perineal deformation values and perineal tears
    Correlation between perineal deformation values and fetal parameters
    Correlation between perineal deformation values and fetal parameters
    Correlation between perineal deformation values and fetal parameters
    Correlation between perineal deformation values and fetal parameters
    Correlation between fetal ultrasound and neonatal parameters and perineal tears
    Correlation between fetal ultrasound and neonatal parameters and perineal tears
    Evolution of the elasticity of the perineal body and the SAE during delivery
    Evolution of the elasticity of the perineal body and the SAE during delivery
    Correlation between elasticity of the perineal body and perineal tears
    Correlation between elasticity of the perineal body and perineal tears
    Correlation between elasticity of the perineal body and perineal tears
    Correlation between elasticity of the perineal body and perineal tears
    Correlation between the elasticity of the external anal sphincter and perineal tears
    Correlation between the elasticity of the external anal sphincter and perineal tears
    Correlation between the elasticity of the external anal sphincter and perineal tears
    Correlation between the elasticity of the external anal sphincter and perineal tears

    Full Information

    First Posted
    September 19, 2022
    Last Updated
    September 22, 2022
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05556304
    Brief Title
    In Vivo Evaluation of Perineal Mechanical Properties During Childbirth
    Acronym
    MecaPer
    Official Title
    In Vivo Evaluation of Perineal Mechanical Properties During Childbirth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2022 (Anticipated)
    Study Completion Date
    October 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    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
    The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.
    Detailed Description
    The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Perineum; Rupture, Perineum; Tear, Perineal Tear
    Keywords
    perineal tear, hyperelasticity

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    prospective, longitudinal and single-center study
    Masking
    None (Open Label)
    Masking Description
    The study design includes a consultation during pregnancy between 36 and 38 weeks of gestation and an assessment in the delivery room during childbirth
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    assessment in the 8th month of pregnancy and during delivery
    Arm Type
    Other
    Arm Description
    The study design includes a consultation during pregnancy between 36 and 38 weeks of gestation and an assessment in the delivery room during childbirth
    Intervention Type
    Other
    Intervention Name(s)
    assessment in the 8th month of pregnancy and during delivery
    Intervention Description
    Day 0: presentation of the study During pregnancy between Day 0 and 36-38SA: inclusion During pregnancy: collection of pelvic MRI data if performed during pregnancy for maternal or fetal reasons Between 36 and 38 WG: collection of demographic, obstetrical, fetal ultrasound and clinical data / Perineal elastographic recording / Recording of the perineal deformation by stereovision camera In the delivery room, at the beginning of labor and before pushing: collection of clinical data / Collection of obstetrical ultrasound data / Perineal elastographic recordings / Recording of the perineal deformation by stereovision camera In the delivery room, during expulsion : recording of the perineal deformation by stereovision camera In the delivery room, after childbirth: collection of obstetrical, clinical and neonatal data / Perineal elastographic recordings / Cephalic and shoulder measurements of the newborn with a tape measure
    Primary Outcome Measure Information:
    Title
    maximum value of equivalent deformation obtained by stereovision camera
    Description
    maximum value of equivalent deformation obtained by stereovision camera
    Time Frame
    delivery
    Secondary Outcome Measure Information:
    Title
    Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB
    Description
    Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB
    Time Frame
    pregnancy
    Title
    Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB
    Description
    elta between the minimum and maximum width of GH, and between the maximum and minimum length of PB
    Time Frame
    delivery
    Title
    Correlation between perineal deformation values and perineal tears
    Description
    Correlation between perineal deformation values and perineal tears
    Time Frame
    delivery
    Title
    Correlation between perineal deformation values and fetal parameters
    Description
    Correlation between perineal deformation values and fetal parameters
    Time Frame
    pregnancy
    Title
    Correlation between perineal deformation values and fetal parameters
    Description
    Correlation between perineal deformation values and fetal parameters
    Time Frame
    delivery
    Title
    Correlation between fetal ultrasound and neonatal parameters and perineal tears
    Description
    Correlation between fetal ultrasound and neonatal parameters and perineal tears
    Time Frame
    delivery
    Title
    Evolution of the elasticity of the perineal body and the SAE during delivery
    Description
    Evolution of the elasticity of the perineal body and the SAE during delivery
    Time Frame
    delivery
    Title
    Correlation between elasticity of the perineal body and perineal tears
    Description
    Correlation between elasticity of the perineal body and perineal tears
    Time Frame
    pregnancy
    Title
    Correlation between elasticity of the perineal body and perineal tears
    Description
    Correlation between elasticity of the perineal body and perineal tears
    Time Frame
    delivery
    Title
    Correlation between the elasticity of the external anal sphincter and perineal tears
    Description
    Correlation between the elasticity of the external anal sphincter and perineal tears
    Time Frame
    pregnancy
    Title
    Correlation between the elasticity of the external anal sphincter and perineal tears
    Description
    Correlation between the elasticity of the external anal sphincter and perineal tears
    Time Frame
    delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Pregnant and volunteer women >18 years old Primiparous With a singleton pregnancy No objection from the subject and the spouse to participate in the study Exclusion Criteria: History of prior delivery or c-section History of perineal troubles BMI > à 35 mg/m² History of chronic muscular disease or connective tissue pathology Psychiatric pathology requiring hospitalization Patients who do not understand the French language Legal incapacity or limited legal capacity Patients unlikely to cooperate

    12. IPD Sharing Statement

    Learn more about this trial

    In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

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