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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Placental Elastography; Fetal Monitoring
• Intervention / Treatment: Other: Sonographic measure of placental elasticity and viscosity

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All the patients; Sonographic measure of placental elasticity and viscosity	Other: Sonographic measure of placental elasticity and viscosity; Sonographic measure of placental elasticity and viscosity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placental elasticity in kilopascals (kPa)	beginning of the labor	Day 1
Placental viscosity in Pascal.seconde (Pa.s)	beginning of the labor	Day 1
Placental elasticity in kilopascals (kPa)	beginning of the active phase of the first stage of labor	Day 1
Placental viscosity in Pascal.seconde (Pa.s)	beginning of the active phase of the first stage of labor	Day 1
Placental elasticity in kilopascals (kPa)	passive phase of the second stage of labor	Day 1
Placental viscosity in Pascal.seconde (Pa.s)	passive phase of the second stage of labor	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placental elasticity in kilopascals (kPa)	in case of oxytocin infusion	Day 1
Placental viscosity in Pascal.seconde (Pa.s)	in case of oxytocin infusion	Day 1
Placental elasticity in kilopascals (kPa)	in case of abnormal FHR	Day 1
Placental viscosity in Pascal.seconde (Pa.s)	in case of abnormal FHR	Day 1
Placental elasticity in kilopascals (kPa)	ex-vivo after placental expulsion	Day 1
Placental viscosity in Pascal.seconde (Pa.s)	ex-vivo after placental expulsion	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Fetal Diseases; Pregnancy Complications; Hypoxia; Fetal Hypoxia
• Other Study ID Numbers: 2021/652

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No