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
About this trial
This is an interventional diagnostic trial for Placental Elastography
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
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
NCT ID
NCT05510349
First Posted
August 8, 2022
Last Updated
August 19, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
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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