Follow up of Increased Nuchal Translucency :Study of 2010 to 2018 of Limoges Hospital

NCT ID: NCT04028453

Last Updated: 2021-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

392 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-25

Study Completion Date

2020-10-25

Brief Summary

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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.

Detailed Description

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Increased NT superior than 95th percentile (Nicolaides curves) during the ultrasound of the first trimester, are associated to common chromosomal abnormalities. It's therefore necessary to make amniocentesis and to analyze karyotyping and Genomic microarrays, also known as chromosomal microarrays (CMA). In euploid foetus, increased NT is also associated with structural defects or genetic syndromes. Additionally, the overall long-term growth of euploid children with increased NT is not much known. The majority (98%) of euploid children with a normal second trimester ultrasound is apparently healthy in the short run. The investigator's objective is to evaluate in a retrospective way, different events (structural defects, chromosomal or genetic abnormalities) during these pregnancies. In a prospective way, the neurodevelopmental disorders in euploid children will be investigated.

Conditions

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Ultrasound Fetal Medicine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Survey

Intervention Type OTHER

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.

Interventions

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Survey

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Limoges

Limoges, , France

Site Status

Countries

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France

Other Identifiers

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87RI19_0030 (HYPERCLAIR)

Identifier Type: -

Identifier Source: org_study_id

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