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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05510349
Acronym
ELASTOLab
Enrollment
150
Registered
2022-08-22
Start date
2022-10-31
Completion date
2024-02-29
Last updated
2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Monitoring, Placental Elastography

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.

Interventions

OTHERSonographic measure of placental elasticity and viscosity

Sonographic measure of placental elasticity and viscosity

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Sonographic measure of placental elasticity and viscosity

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Placental elasticity in kilopascals (kPa)Day 1beginning of the labor
Placental viscosity in Pascal.seconde (Pa.s)Day 1beginning of the labor

Secondary

MeasureTime frameDescription
Placental elasticity in kilopascals (kPa)Day 1in case of oxytocin infusion
Placental viscosity in Pascal.seconde (Pa.s)Day 1in case of oxytocin infusion

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026