Status:
COMPLETED
Antenatal Detection by Array CGH Genomic Rearrangements Unbalanced Front Uninsulated Thick Neck or a Combination of Two Signs of Ultrasound Calling Normal Karyotype
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Abnormality of the Neck
Fetus; Abnormal, Affecting Management of Pregnancy
Eligibility:
FEMALE
18-45 years
Brief 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 w...
Eligibility Criteria
Inclusion
- 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
- The parturientes in emergency situation,
- Benefiting from a legal protection (guardianship / curatorship)
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03239002
Start Date
July 1 2011
End Date
September 1 2017
Last Update
January 30 2018
Active Locations (1)
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1
Hôpital Jeanne de Flandre - CHRU de Lille
Lille, France