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

Ultrasound Fetal Medicine Clinical Trial

— HYPERCLAIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04028453
• Other study ID #: 87RI19_0030 (HYPERCLAIR)
• Status: Completed
• Start date: October 25, 2019
• Est. completion date: October 25, 2020

Study information

• Verified date: September 2021
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: October 25, 2020
• Est. primary completion date: October 25, 2020
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ultrasound Fetal Medicine

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	CHU de Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Rate of each Pregnancy outcomes	Numbers of alive children, fetal death in utero, abortions on medical grounds, stillborn, children born prematurely	1 year
Secondary	structural defects	Numbers and type term of structural defects	1 year
Secondary	maternofetal infection	number and type of maternofetal infection	1 year
Secondary	postnatal structural defects	Numbers and type of postnatal structural defects	1 year
Secondary	postnatal chromosomal abnormalities	Number and type of postnatal chromosomal abnormalities	1 year
Secondary	postnatal genetic syndromes	Number and type of postnatal genetic syndromes	1 year
Secondary	Determination of a neck thickness threshold at risk of psychomotor developmental delay	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).	1 year
Secondary	Determination of a neck thickness threshold at risk of malformations and requiring the persistence of monthly ultrasound monitoring	Numbers and type of postnatal structural defects	1 year
Secondary	Study of the psychomotor development of nuchal translucency with normal genetic analysis	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).	1 year