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

University of Limoges (UL)

Status: Completed

Conditions: Ultrasound Fetal Medicine

Treatments: Other: Survey

Study type: Observational

Funder types: Other

Identifiers

NCT04028453

87RI19_0030 (HYPERCLAIR)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 392 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

392 participants in 1 patient group

Mother

Description:

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.

Treatment:

Other: Survey