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

Not Applicable

• Conditions: Placental Elastography; Fetal Monitoring
• Interventions: Other: Sonographic measure of placental elasticity and viscosity

• Registration Number: NCT05510349
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-19
• Last Update Submitted: 2022-08-19
• Study First Posted: 2022-08-22
• Last Update Posted: 2022-08-22
• Study Start: 2022-10
• Primary Completion: 2023-10
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All the patients	Sonographic measure of placental elasticity and viscosity	Sonographic measure of placental elasticity and viscosity

Primary Outcome Measures

Name	Time	Method
Placental viscosity in Pascal.seconde (Pa.s)	Day 1	passive phase of the second stage of labor
Placental elasticity in kilopascals (kPa)	Day 1	passive phase of the second stage of labor

Secondary Outcome Measures

Name	Time	Method
Placental elasticity in kilopascals (kPa)	Day 1	ex-vivo after placental expulsion
Placental viscosity in Pascal.seconde (Pa.s)	Day 1	ex-vivo after placental expulsion