Status:
UNKNOWN
Realization of Sequencing of All Known Human Genes in Case of Detection of Cerebral, Renal or Ophthalmological Fetal Malformations During Pregnancy in Order to Make an Etiological Diagnosis and to Precise the Fetal Prognosis
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Fetal Malformation
Pregnancy Related
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Congenital malformations concern 3% of pregnancies; most of them can be seen during pregnancy. For some malformations, an invasive sample (trophoblast biopsy or amniocentesis) is proposed to search a ...
Eligibility Criteria
Inclusion
- Father and mother of an unborn child past the age of majority
- Consent dated and signed by the mother and by the father
- Father and mother able to understand the objectives and risks of the study
- For the mother, pregnancy in progress (between 12 and 34 weeks)
- For the mother, pregnancy with the presence of a malformation on ultrasound, confirmed by a doctor from the multidisciplinary diagnostic prenatal center, entering into the indications retained for this study
- Clinical validation of the couple's eligibility by an expert for some of selected indications
- Father and mother affiliated to a social protection health
Exclusion
- Identified genetic or chromosomal abnormality explaining the observed malformation
- Inability to give informations to the father and / or mother (father or mother in emergency or life-threatening situation)
- Father and / or mother under the protection of justice
- Father and / or mother under guardianship or curatorship
- Nursing woman
Key Trial Info
Start Date :
August 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04406480
Start Date
August 5 2020
End Date
September 1 2023
Last Update
November 13 2020
Active Locations (12)
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1
CHu de Besançon
Besançon, France, 25030
2
CHU de Dijon
Dijon, France, 21079
3
Hospices Civils de Lyon
Lyon, France
4
Groupe Hospitalier Region Mulhouse Et Sud Alsace
Mulhouse, France, 68070