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

Pregnancy Complications Clinical Trial

— ELASTOMAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870608
• Other study ID #: API/2015/60
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: March 14, 2017

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 14, 2017
• Est. primary completion date: November 14, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Pregnancy Complications
• Premature Birth

Intervention

Other:
• lung and liver elastography measurement of fetus

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	For pretern larbor group: day of hospitalization for preterm labor, then 2 days later. For control group, both measurements at 2-day intervals