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

NCT05510349 | Unknown

• 1 other identifier: 2021/652
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Placental Elastography; Fetal Monitoring

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Placental elasticity in kilopascals (kPa)

  Day 1

• Placental viscosity in Pascal.seconde (Pa.s)

  Day 1

• Placental elasticity in kilopascals (kPa)

  Day 1

• Placental viscosity in Pascal.seconde (Pa.s)

  Day 1

• Placental elasticity in kilopascals (kPa)

  Day 1

Study Arms (1)

All the patients

EXPERIMENTAL

Sonographic measure of placental elasticity and viscosity

Other: Sonographic measure of placental elasticity and viscosity

Interventions

Sonographic measure of placental elasticity and viscosity OTHER

Sonographic measure of placental elasticity and viscosity

All the patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• gestational diabetes
• preeclampsia
• intrauterine growth restriction

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Interventions

Viscosity

Intervention Hierarchy (Ancestors)

Chemical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sonographic measure of placental elasticity and viscosity

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 22, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: February 1, 2024
• Last Updated: August 22, 2022

Record last verified: 2021-10