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Completed

NCT Number: NCT03239002

Antenatal Detection by Array CGH Genomic Rearrangements Unbalanced Front Uninsulated Thick Neck or a Combination of Two Signs of Ultrasound Calling Normal Karyotype

This is the first study with a real diagnostic and prognostic focus in prenatal. In addition to this innovative aspect, the identification of cryptic imbalances in fetuses with malformative syndrome would be an invaluable resource for the identification of new genes involved in development, as is already the case for postnatal studies.

This research aims to:

1. to test the feasibility of this protocol, ie the practical application of this new technology in the context of prenatal diagnosis, 2. demonstrate and evaluate the possible involvement of cryptic chromosomal abnormalities in fetuses with a thick neck associated with other malformations and recruited on the strict criteria mentioned above, 3. assist in the diagnosis of these fetuses and genetic information for their families, 4. identify new regions of the genome potentially involved in the occurrence of congenital malformations.

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Key information

Conditions

Abnormality of the Neck Antisocial Personality Disorder Fetus; Abnormal, Affecting Management of Pregnancy Mental Disorders Personality Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Jeanne de Flandre - CHRU de Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • a karyotype performed from a trophoblast biopsy or an amniotic fluid puncture is normal or apparently balanced.
  • The fetuses included in the study should have one of the following two criteria:
  • 1) Thick bone (greater than 99th percentile, between week 11 and week 13 of amenorrhoea plus 6 days, correlated to a cranio-caudal length measured between 45 and 84 mm) detected in the first trimester of pregnancy associated with One or more echographic sign (s).
  • 2) At least two ultrasound call signs involving the following organs (heart, kidney, brain, limbs, digestive tract, face) or intrauterine growth retardation (less than 3rd percentile) associated with one of these Signs of appeal.

Exclusion criteria

  • The parturientes in emergency situation,
  • Benefiting from a legal protection (guardianship / curatorship)

Treatment and study plan

Primary outcomes

  1. Number of patient with Ultrasound call signs (thick neck and / or any other organ concerned)

    Time frame: During the first trimester of pregnancy

Secondary outcomes

  1. CGH-array analysis

    Time frame: During the first trimester of pregnancy

    CGH-array result: normal, deletion or duplication, de novo or inherited, size, type and number of genes involved

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: CGH Array

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Aug 3, 2017
Registry last updated
Jan 30, 2018

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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