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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2024-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Placental Elastography Fetal Monitoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Sonographic measure of placental elasticity and viscosity

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All the patients

Sonographic measure of placental elasticity and viscosity

Group Type EXPERIMENTAL

Sonographic measure of placental elasticity and viscosity

Intervention Type OTHER

Sonographic measure of placental elasticity and viscosity

Interventions

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Sonographic measure of placental elasticity and viscosity

Intervention Type OTHER

Eligibility Criteria

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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