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Clinical Trials/NCT02870608
NCT02870608CompletedNot Applicable

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

Centre Hospitalier Universitaire de Besancon1 site in 1 country103 target enrollmentStarted: April 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
103
Locations
1
Primary Endpoint
Evolution over 48 hours of the fetal lung elasticity coefficient measure in kilopascals (kPa) (compared to the fetal liver)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

preterm labor group

Experimental

Pregnant women hospitalized for preterm labor

Intervention: lung and liver elastography measurement of fetus (Other)

control group

Other

Pregnant women with a normal pregnancy

Intervention: lung and liver elastography measurement of fetus (Other)

Outcomes

Primary Outcomes

Evolution over 48 hours of the fetal lung elasticity coefficient measure in kilopascals (kPa) (compared to the fetal liver)

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

The dates of elastography exams controls patients will be distributed a week of amenorrhea (WA) between 24 and 34 WA.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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