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

March 4, 2021 updated by: Centre Hospitalier Universitaire de Besancon
The objective of the study is to evaluated the evolution of the LLE ratio (Lung to Liver Elastography ratio) during normal pregnancy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Doubs
      • Besançon, Doubs, France, 25000
        • CHU Jean Minjoz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregnant women with a normal pregnancy
Assesment of fetal lung and liver stiffness with 2D Ultrasounds Shear Wave Elastography
Other: lung and liver elastography measurement of fetus
Other: lung and liver elastography measurement of fetus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Lung to liver Elastography ratio (LLE ratio) between 24 and 39 weeks of amenorrhea
Time Frame: measurements at: 24, 28, 32, 36, 39 weeks of amenorrhea (WA)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2019

Primary Completion (Actual)

March 20, 2019

Study Completion (Actual)

March 4, 2021

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

February 7, 2019

First Posted (Actual)

February 8, 2019

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • API/2018/95

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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