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Completed

NCT Number: NCT04028453

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

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.

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Key information

Conditions

Ultrasound Fetal Medicine Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Limoges

Limoges, 87042, France

About this study

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.

Who can participate

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

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

Treatment and study plan

Survey

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.

Primary outcomes

  1. Number of chromosomal abnormalities on fetuses with increased nuchal translucency

    Time frame: 6 months

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

  2. Number structural defects on fetuses with increased nuchal translucency

    Time frame: 6 months

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

  3. Number of genetic syndromes on fetuses with increased nuchal translucency

    Time frame: 6 months

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

Secondary outcomes

  1. Rate of each Pregnancy outcomes

    Time frame: 1 year

    Numbers of alive children, fetal death in utero, abortions on medical grounds, stillborn, children born prematurely

  2. structural defects

    Time frame: 1 year

    Numbers and type term of structural defects

  3. maternofetal infection

    Time frame: 1 year

    number and type of maternofetal infection

  4. postnatal structural defects

    Time frame: 1 year

    Numbers and type of postnatal structural defects

  5. postnatal chromosomal abnormalities

    Time frame: 1 year

    Number and type of postnatal chromosomal abnormalities

  6. postnatal genetic syndromes

    Time frame: 1 year

    Number and type of postnatal genetic syndromes

  7. Determination of a neck thickness threshold at risk of psychomotor developmental delay

    Time frame: 1 year

    Neurodevelopmental evaluation score of Age Stage Questionnaire ASQ-3 (for 2 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years children) or Global School Adaptation GSA (from 6 to 8 years children).

  8. Determination of a neck thickness threshold at risk of malformations and requiring the persistence of monthly ultrasound monitoring

    Time frame: 1 year

    Numbers and type of postnatal structural defects

  9. Study of the psychomotor development of nuchal translucency with normal genetic analysis

    Time frame: 1 year

    Neurodevelopmental evaluation score of Age Stage Questionnaire (ASQ-3) (for 2 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years children without genetic abnormalities) or Global School Adaptation (GSA) (from 6 to 8 years children without genetic abnormalities).

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: HYPERCLAIR

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 22, 2019
Registry last updated
Sep 8, 2021

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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