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Clinical Trials/NCT05510349
NCT05510349
Unknown
Not Applicable

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

Centre Hospitalier Universitaire de Besancon0 sites150 target enrollmentOctober 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Placental Elastography
Sponsor
Centre Hospitalier Universitaire de Besancon
Enrollment
150
Primary Endpoint
Placental viscosity in Pascal.seconde (Pa.s)
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2022
End Date
February 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Placental viscosity in Pascal.seconde (Pa.s)

Time Frame: Day 1

passive phase of the second stage of labor

Placental elasticity in kilopascals (kPa)

Time Frame: Day 1

passive phase of the second stage of labor

Secondary Outcomes

  • Placental elasticity in kilopascals (kPa)(Day 1)
  • Placental viscosity in Pascal.seconde (Pa.s)(Day 1)

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