Interest of Measuring Lung Elasticity ELASTOgraphy in the Fetus in the Case of PreMAture Childbirth Threat

NCT ID: NCT02870608

Last Updated: 2018-07-18

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

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-03-14

Brief Summary

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The objective of the study was to evaluated the feasibility and reproducibility of the measurement of lung elasticity report / fetal liver according to gestational age in a group of patients with a normal course of pregnancy and in a group of Patients at risk of preterm delivery.

Detailed Description

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Conditions

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Pregnancy Complications Obstetric Labor, Premature

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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preterm labor group

Pregnant women hospitalized for preterm labor

Group Type EXPERIMENTAL

lung and liver elastography measurement of fetus

Intervention Type OTHER

control group

Pregnant women with a normal pregnancy

Group Type OTHER

lung and liver elastography measurement of fetus

Intervention Type OTHER

Interventions

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lung and liver elastography measurement of fetus

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* major pregnant women
* singleton pregnancy


* major pregnant women
* singleton pregnancy
* hospitalized for threatened premature birth between 24 and 34 WA
* Indication of a cure corticosteroid betamethasone

Exclusion Criteria

* maternal conditions of pregnancy: diabetes gestational, pregnancy-induced hypertension, preeclampsia
* fetal lung diseases
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

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 de Besançon

Besançon, , France

Site Status

Countries

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France

References

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Mottet N, Aubry S, Vidal C, Boiteux G, Metz JP, Riethmuller D, Pazart L, Ramanah R. Feasibility of 2-D ultrasound shear wave elastography of fetal lungs in case of threatened preterm labour: a study protocol. BMJ Open. 2017 Dec 26;7(12):e018130. doi: 10.1136/bmjopen-2017-018130.

Reference Type DERIVED
PMID: 29282263 (View on PubMed)

Other Identifiers

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API/2015/60

Identifier Type: -

Identifier Source: org_study_id

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