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Prevention of Per-partum Fetal Hypoxia: Measure of Placental Elasticity and Viscosity During Labor (ELASTOLab)

Primary Purpose

Placental Elastography, Fetal Monitoring

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sonographic measure of placental elasticity and viscosity
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Placental Elastography

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • singleton pregnancy
  • spontaneous labor at term
  • body mass index < 30 at the beginning of the pregnancy
  • anterior, lateral or fundal placenta
  • epidural analgesia at the beginning of the labor
  • normal fetal heart rate at the beginning of the labor

Exclusion Criteria:

  • gestational diabetes
  • preeclampsia
  • intrauterine growth restriction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    All the patients

    Arm Description

    Sonographic measure of placental elasticity and viscosity

    Outcomes

    Primary Outcome Measures

    Placental elasticity in kilopascals (kPa)
    beginning of the labor
    Placental viscosity in Pascal.seconde (Pa.s)
    beginning of the labor
    Placental elasticity in kilopascals (kPa)
    beginning of the active phase of the first stage of labor
    Placental viscosity in Pascal.seconde (Pa.s)
    beginning of the active phase of the first stage of labor
    Placental elasticity in kilopascals (kPa)
    passive phase of the second stage of labor
    Placental viscosity in Pascal.seconde (Pa.s)
    passive phase of the second stage of labor

    Secondary Outcome Measures

    Placental elasticity in kilopascals (kPa)
    in case of oxytocin infusion
    Placental viscosity in Pascal.seconde (Pa.s)
    in case of oxytocin infusion
    Placental elasticity in kilopascals (kPa)
    in case of abnormal FHR
    Placental viscosity in Pascal.seconde (Pa.s)
    in case of abnormal FHR
    Placental elasticity in kilopascals (kPa)
    ex-vivo after placental expulsion
    Placental viscosity in Pascal.seconde (Pa.s)
    ex-vivo after placental expulsion

    Full Information

    First Posted
    August 8, 2022
    Last Updated
    August 19, 2022
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05510349
    Brief Title
    Prevention of Per-partum Fetal Hypoxia: Measure of Placental Elasticity and Viscosity During Labor
    Acronym
    ELASTOLab
    Official Title
    Prevention of Per-partum Fetal Hypoxia: Measure of Placental Elasticity and Viscosity During Labor
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    February 2024 (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
    Fetal heart rate (FHR) monitoring during labor aims to detect fetuses at risk of intrapartum hypoxia in order to accelerate their birth before the constitution of sequelae such as anoxic encephalopathy and cerebral palsy. But the positive predictive value of FHR monitoring is low, and many second-line tests have been proposed but none of them has been proven to be conclusive. Measure of placental elasticity and viscosity during labor could be a new second line test to complete the FHR monitoring. Several studies have shown that placental elasticity is increased in case of gestational diabetes, preeclampsia, or intrauterine growth restriction, but no study has focused on placental elasticity during labor. The investigators hypothesize that placental elasticity and viscosity could reflect the quality of maternal-fetal exchanges during labor, and could help to detect fetus at risk of intrapartum hypoxia. The first aim of this study is to describe the values of placental elasticity and viscosity during different points in the labor: beginning of the labor, beginning of the active phase of the first stage of labor, and passive phase of the second stage of labor. Secondary aims of this study are: to describe the values of placental elasticity and viscosity in case of oxytocin infusion, in case of abnormal FHR, and ex-vivo after placental expulsion. This unicentric observational prospective study will include 150 patients with singleton pregnancy, without pathology, with spontaneous labor at term.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Placental Elastography, Fetal Monitoring

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Sonographic measure of placental elasticity and viscosity
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    All the patients
    Arm Type
    Experimental
    Arm Description
    Sonographic measure of placental elasticity and viscosity
    Intervention Type
    Other
    Intervention Name(s)
    Sonographic measure of placental elasticity and viscosity
    Intervention Description
    Sonographic measure of placental elasticity and viscosity
    Primary Outcome Measure Information:
    Title
    Placental elasticity in kilopascals (kPa)
    Description
    beginning of the labor
    Time Frame
    Day 1
    Title
    Placental viscosity in Pascal.seconde (Pa.s)
    Description
    beginning of the labor
    Time Frame
    Day 1
    Title
    Placental elasticity in kilopascals (kPa)
    Description
    beginning of the active phase of the first stage of labor
    Time Frame
    Day 1
    Title
    Placental viscosity in Pascal.seconde (Pa.s)
    Description
    beginning of the active phase of the first stage of labor
    Time Frame
    Day 1
    Title
    Placental elasticity in kilopascals (kPa)
    Description
    passive phase of the second stage of labor
    Time Frame
    Day 1
    Title
    Placental viscosity in Pascal.seconde (Pa.s)
    Description
    passive phase of the second stage of labor
    Time Frame
    Day 1
    Secondary Outcome Measure Information:
    Title
    Placental elasticity in kilopascals (kPa)
    Description
    in case of oxytocin infusion
    Time Frame
    Day 1
    Title
    Placental viscosity in Pascal.seconde (Pa.s)
    Description
    in case of oxytocin infusion
    Time Frame
    Day 1
    Title
    Placental elasticity in kilopascals (kPa)
    Description
    in case of abnormal FHR
    Time Frame
    Day 1
    Title
    Placental viscosity in Pascal.seconde (Pa.s)
    Description
    in case of abnormal FHR
    Time Frame
    Day 1
    Title
    Placental elasticity in kilopascals (kPa)
    Description
    ex-vivo after placental expulsion
    Time Frame
    Day 1
    Title
    Placental viscosity in Pascal.seconde (Pa.s)
    Description
    ex-vivo after placental expulsion
    Time Frame
    Day 1

    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: singleton pregnancy spontaneous labor at term body mass index < 30 at the beginning of the pregnancy anterior, lateral or fundal placenta epidural analgesia at the beginning of the labor normal fetal heart rate at the beginning of the labor Exclusion Criteria: gestational diabetes preeclampsia intrauterine growth restriction

    12. IPD Sharing Statement

    Learn more about this trial

    Prevention of Per-partum Fetal Hypoxia: Measure of Placental Elasticity and Viscosity During Labor

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