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

Primary Purpose

Pregnancy Complications, Obstetric Labor, Premature

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
lung and liver elastography measurement of fetus
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pregnancy Complications focused on measuring Elastography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria for control group :

  • major pregnant women
  • singleton pregnancy

Inclusion Criteria for control group :

  • 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

Sites / Locations

  • CHU de Besançon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

preterm labor group

control group

Arm Description

Pregnant women hospitalized for preterm labor

Pregnant women with a normal pregnancy

Outcomes

Primary Outcome Measures

Evolution over 48 hours of the fetal lung elasticity coefficient measure in kilopascals (kPa) (compared to the fetal liver)
The dates of elastography exams controls patients will be distributed a week of amenorrhea (WA) between 24 and 34 WA.

Secondary Outcome Measures

Full Information

First Posted
July 21, 2016
Last Updated
July 17, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02870608
Brief Title
Interest of Measuring Lung Elasticity ELASTOgraphy in the Fetus in the Case of PreMAture Childbirth Threat
Acronym
ELASTOMAP
Official Title
Interest of Measuring Lung Elasticity ELASTOgraphy in the Fetus in the Case of PreMAture Childbirth Threat
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 14, 2016 (Actual)
Study Completion Date
March 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications, Obstetric Labor, Premature
Keywords
Elastography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
preterm labor group
Arm Type
Experimental
Arm Description
Pregnant women hospitalized for preterm labor
Arm Title
control group
Arm Type
Other
Arm Description
Pregnant women with a normal pregnancy
Intervention Type
Other
Intervention Name(s)
lung and liver elastography measurement of fetus
Primary Outcome Measure Information:
Title
Evolution over 48 hours of the fetal lung elasticity coefficient measure in kilopascals (kPa) (compared to the fetal liver)
Description
The dates of elastography exams controls patients will be distributed a week of amenorrhea (WA) between 24 and 34 WA.
Time Frame
For pretern larbor group: day of hospitalization for preterm labor, then 2 days later. For control group, both measurements at 2-day intervals

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for control group : major pregnant women singleton pregnancy Inclusion Criteria for control group : 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
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29282263
Citation
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.
Results Reference
derived

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

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