NCT04028453

Brief Summary

The ultrasound of the first trimester allows to determinate the pregnancy beginning, the type of pregnancy and also to detect increased nuchal translucency (NT). Fetuses with common chromosomal abnormalities (trisomies 21, 18 and 13 and monosomy X) and structural abnormalities (particularly cardiac defects) and single-gene disorders frequently show increased NT. The purpose of this study is to evaluate in the population of Limousin, the type and frequency of these abnormalities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
392

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

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

July 15, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 25, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2020

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

July 15, 2019

Last Update Submit

September 7, 2021

Conditions

Ultrasound Fetal Medicine

Keywords

Increased nuchal translucencyprenatal diagnosiskaryotype analysischromosome micro-array analysisneurodevelopmental disorderseuploid children

Outcome Measures

Primary Outcomes (3)

  • Number of chromosomal abnormalities on fetuses with increased nuchal translucency

    Characterization of fetuses with increased nuchal translucency by Identification of chromosomal abnormalities, structural defects and genetic syndromes on fetuses with increased nuchal translucency

    6 months

  • Number structural defects on fetuses with increased nuchal translucency

    Characterization of fetuses with increased nuchal translucency by Identification of chromosomal abnormalities, structural defects and genetic syndromes on fetuses with increased nuchal translucency

    6 months

  • Number of genetic syndromes on fetuses with increased nuchal translucency

    Characterization of fetuses with increased nuchal translucency by Identification of chromosomal abnormalities, structural defects and genetic syndromes on fetuses with increased nuchal translucency

    6 months

Secondary Outcomes (9)

  • Rate of each Pregnancy outcomes

    1 year

  • structural defects

    1 year

  • maternofetal infection

    1 year

  • postnatal structural defects

    1 year

  • postnatal chromosomal abnormalities

    1 year

  • +4 more secondary outcomes

Study Arms (1)

Mother

There will be a first part with a retrospective study in order to collect pregnancy data to answer to the primary endpoint. Then, there will be a prospective part where mothers and their children will have to answer an evaluation questionnaire.

Other: Survey

Interventions

SurveyOTHER

There will be a first part with a retrospective study in order to collect pregnancy data to answer to the primary endpoint. Then, there will be a prospective part where mothers and their children will have to answer an evaluation survey.

Mother

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with nuchal translucency of the fetus\> 95th percentile in the first trimester of pregnancy

You may qualify if:

  • Increased nucal translucency (NT) \> 95e percentile on the pregnancy's first trimester
  • Monofoetal pregnancy
  • Twin pregnancy (biamniotic bichorial)
  • Adult patients

You may not qualify if:

  • Increased NT \< 95e percentile on the pregnancy's first trimester
  • Increased NT \> 95e percentile on the pregnancy's second trimester
  • Twin pregnancy (biamniotic monochorial), triple or more gestation
  • Underage patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Limoges

Limoges, 87042, France

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 22, 2019

Study Start

October 25, 2019

Primary Completion

October 25, 2020

Study Completion

October 25, 2020

Last Updated

September 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)