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

Fetal Monitoring Clinical Trial

— ELASTOLab  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05510349
• Other study ID #: 2021/652
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: February 2024

Study information

• Verified date: October 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Hypoxia
• Fetal Monitoring
• Hypoxia

Intervention

Other:
• Sonographic measure of placental elasticity and viscosity
Sonographic measure of placental elasticity and viscosity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placental elasticity in kilopascals (kPa)	beginning of the labor	Day 1
Primary	Placental viscosity in Pascal.seconde (Pa.s)	beginning of the labor	Day 1
Primary	Placental elasticity in kilopascals (kPa)	beginning of the active phase of the first stage of labor	Day 1
Primary	Placental viscosity in Pascal.seconde (Pa.s)	beginning of the active phase of the first stage of labor	Day 1
Primary	Placental elasticity in kilopascals (kPa)	passive phase of the second stage of labor	Day 1
Primary	Placental viscosity in Pascal.seconde (Pa.s)	passive phase of the second stage of labor	Day 1
Secondary	Placental elasticity in kilopascals (kPa)	in case of oxytocin infusion	Day 1
Secondary	Placental viscosity in Pascal.seconde (Pa.s)	in case of oxytocin infusion	Day 1
Secondary	Placental elasticity in kilopascals (kPa)	in case of abnormal FHR	Day 1
Secondary	Placental viscosity in Pascal.seconde (Pa.s)	in case of abnormal FHR	Day 1
Secondary	Placental elasticity in kilopascals (kPa)	ex-vivo after placental expulsion	Day 1
Secondary	Placental viscosity in Pascal.seconde (Pa.s)	ex-vivo after placental expulsion	Day 1