NCT02870608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2017

Completed
Last Updated

July 18, 2018

Status Verified

January 1, 2018

Enrollment Period

8 months

First QC Date

July 21, 2016

Last Update Submit

July 17, 2018

Conditions

Pregnancy ComplicationsObstetric Labor, Premature

Keywords

Elastography

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

preterm labor group

EXPERIMENTAL

Pregnant women hospitalized for preterm labor

Other: lung and liver elastography measurement of fetus

control group

OTHER

Pregnant women with a normal pregnancy

Other: lung and liver elastography measurement of fetus

Interventions

lung and liver elastography measurement of fetusOTHER
control grouppreterm labor group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • maternal conditions of pregnancy: diabetes gestational, pregnancy-induced hypertension, preeclampsia
  • fetal lung diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

Location

Related Publications (1)

  • 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.

    PMID: 29282263DERIVED

MeSH Terms

Conditions

Pregnancy ComplicationsObstetric Labor, Premature

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObstetric Labor Complications

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2016

First Posted

August 17, 2016

Study Start

April 1, 2016

Primary Completion

November 14, 2016

Study Completion

March 14, 2017

Last Updated

July 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)