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CompletedNCT03239002CGH ArrayUpdated Jan 30, 2018

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

An observational study in Abnormality of the Neck and Fetus; Abnormal, Affecting Management of Pregnancy, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.
02

Conditions studied

  • Abnormality of the Neck
  • Fetus; Abnormal, Affecting Management of Pregnancy
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In context

Congenital Abnormalities

980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.

This study's enrollment of 200 is above the median of 153 across 446 observational studies indexed under Congenital Abnormalities.

Browse Congenital Abnormalities studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

the parturients aged 18 to 45 years for whom a karyotype performed from a trophoblast biopsy or amniotic fluid puncture is normal or apparently balanced

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).
    1. 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

Exclusion Criteria:

  • The parturientes in emergency situation,
  • Benefiting from a legal protection (guardianship / curatorship)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No
06

What researchers measure

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

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

    Time frame: During the first trimester of pregnancy

07

Study locations

1 site
  • Hôpital Jeanne de Flandre - CHRU de Lille
    Lille, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03239002
Lead sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
Responsible party
Sponsor
First posted
Aug 3, 2017
Start date
Jul 2011
Primary completion
Sep 2017
Completion
Sep 2017
Last update
Jan 30, 2018

Study contacts

Véronique HOUFFLIN-DEBARGE, MD, PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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