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

NCT ID: NCT03834805

Last Updated: 2021-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-07

Study Completion Date

2021-03-04

Brief Summary

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

Detailed Description

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Conditions

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Pregnant Woman

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pregnant women with a normal pregnancy

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

Group Type EXPERIMENTAL

lung and liver elastography measurement of fetus

Intervention Type OTHER

Other: lung and liver elastography measurement of fetus

Interventions

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lung and liver elastography measurement of fetus

Other: lung and liver elastography measurement of fetus

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Jean Minjoz

Besançon, Doubs, France

Site Status

Countries

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France

References

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Nallet C, Pazart L, Cochet C, Vidal C, Metz JP, Jacquet E, Gorincour G, Mottet N. Prenatal quantification of human foetal lung and liver elasticities between 24 and 39 weeks of gestation using 2D shear wave elastography. Eur Radiol. 2022 Aug;32(8):5559-5567. doi: 10.1007/s00330-022-08654-1. Epub 2022 Mar 10.

Reference Type DERIVED
PMID: 35267093 (View on PubMed)

Other Identifiers

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API/2018/95

Identifier Type: -

Identifier Source: org_study_id

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