NCT03834805

Brief Summary

The objective of the study is to evaluated the evolution of the LLE ratio (Lung to Liver Elastography ratio) during normal pregnancy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

February 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2021

Completed
Last Updated

March 5, 2021

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

February 4, 2019

Last Update Submit

March 4, 2021

Conditions

Pregnant Woman

Outcome Measures

Primary Outcomes (1)

  • Change of Lung to liver Elastography ratio (LLE ratio) between 24 and 39 weeks of amenorrhea

    Evolution of the fetal lung elasticity coefficient measured in kilopascals (kPa) compared to the fetal liver elasticity

    measurements at: 24, 28, 32, 36, 39 weeks of amenorrhea (WA)

Study Arms (1)

Pregnant women with a normal pregnancy

EXPERIMENTAL

Assesment of fetal lung and liver stiffness with 2D Ultrasounds Shear Wave Elastography

Other: lung and liver elastography measurement of fetus

Interventions

lung and liver elastography measurement of fetusOTHER

Other: lung and liver elastography measurement of fetus

Pregnant women with a normal pregnancy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • major pregnant women
  • singleton pregnancy

You may not qualify if:

  • foetus:
  • fetal pulmonary disease
  • fetal liver disease
  • chromosome fetal abnormalities
  • fetal growth restriction
  • mother:
  • BMI\>30 in beginning of pregnancy
  • premature ruptured membranes
  • high blood pressure
  • pre-eclampsia
  • gestational diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Jean Minjoz

Besançon, Doubs, 25000, France

Location

Related Publications (1)

  • Nallet C, Pazart L, Cochet C, Vidal C, Metz JP, Jacquet E, Gorincour G, Mottet N. Prenatal quantification of human foetal lung and liver elasticities between 24 and 39 weeks of gestation using 2D shear wave elastography. Eur Radiol. 2022 Aug;32(8):5559-5567. doi: 10.1007/s00330-022-08654-1. Epub 2022 Mar 10.

    PMID: 35267093DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2019

First Posted

February 8, 2019

Study Start

February 7, 2019

Primary Completion

March 20, 2019

Study Completion

March 4, 2021

Last Updated

March 5, 2021

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)