Monitoring of Fetal Lung Elasticity by Elastography Between 24 and 39 Weeks (ELASTOPULM)

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Pregnant Woman

Treatments: Other: lung and liver elastography measurement of fetus

Study type: Interventional

Funder types: Other

Identifiers

NCT03834805

API/2018/95

Details and patient eligibility

About

The objective of the study is to evaluated the evolution of the LLE ratio (Lung to Liver Elastography ratio) during normal pregnancy

Enrollment: 74 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• major pregnant women
• singleton pregnancy

Exclusion criteria

foetus:

• fetal pulmonary disease
• fetal liver disease
• chromosome fetal abnormalities
• fetal growth restriction

mother:

• BMI>30 in beginning of pregnancy
• premature ruptured membranes
• high blood pressure
• pre-eclampsia
• gestational diabetes

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Pregnant women with a normal pregnancy

Experimental group

Description:

Assesment of fetal lung and liver stiffness with 2D Ultrasounds Shear Wave Elastography

Treatment:

Other: lung and liver elastography measurement of fetus