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

Pregnant Woman Clinical Trial

— ELASTOPULM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03834805
• Other study ID #: API/2018/95
• Status: Completed
• Phase: N/A
• Start date: February 7, 2019
• Est. completion date: March 4, 2021

Study information

• Verified date: May 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 4, 2021
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnant Woman

Intervention

Other:
• lung and liver elastography measurement of fetus
Other: lung and liver elastography measurement of fetus

Locations

Country	Name	City	State
France	CHU Jean Minjoz	Besançon	Doubs

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Lung to liver Elastography ratio (LLE ratio) between 24 and 39 weeks of amenorrhea	Evolution of the fetal lung elasticity coefficient measured in kilopascals (kPa) compared to the fetal liver elasticity	measurements at: 24, 28, 32, 36, 39 weeks of amenorrhea (WA)