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OpenTrials
Completed

NCT Number: NCT02870608

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

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.

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Key information

Conditions

Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon

Besançon, 25000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lung and liver elastography measurement of fetus

Other

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: ELASTOMAP

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Aug 17, 2016
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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