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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834805
Recruitment Status : Completed
First Posted : February 8, 2019
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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Brief Summary:
The objective of the study is to evaluated the evolution of the LLE ratio (Lung to Liver Elastography ratio) during normal pregnancy

Condition or disease Intervention/treatment Phase
Pregnant Woman Other: lung and liver elastography measurement of fetus Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Monitoring of Fetal Lung Elasticity by Elastography Between 24 and 39 Weeks
Actual Study Start Date : February 7, 2019
Actual Primary Completion Date : March 20, 2019
Actual Study Completion Date : March 4, 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834805


Locations
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France
CHU Jean Minjoz
Besançon, Doubs, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
More Information
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03834805    
Other Study ID Numbers: API/2018/95
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No