Status:
UNKNOWN
Feasibility Study of a New Screening Program for Major Aneuploidies (T21, T18, T13) in the Emilia-Romagna Region (SAPERER)
Lead Sponsor:
Azienda Usl di Bologna
Conditions:
Autosomal Aneuploidy
Eligibility:
FEMALE
18+ years
Brief Summary
The study is promoted by the Emilia Romagna Region which identified in the Bologna AUSL the coordinating center (Unità Operativa Complessa Laboratorio Unico Metropolitano, LUM, Maggiore Hospital). The...
Eligibility Criteria
Inclusion
- Pregnant women resident in the Emilia Romagna region who access the combined test at regional counseling centers and hospital prenatal clinics.
- Women able to understand the information, participate in pre-test counseling and provide informed consent.
Exclusion
- Women under the age of 18 and/or unable to give informed consent
- pregnancies with more than two twins
- certain evidence of initial twinning, with subsequent disappearance of one of the twins (vanishing twin)
- known maternal chromosome mosaicisms present in the mother and involving the chromosomes subject to investigation
- presence of neoplasia in pregnant women
- previous allogeneic transplantation in pregnant women
- immunotherapy, radiotherapy or hemotransfusion performed in the pregnant woman within the previous 3 months.
Key Trial Info
Start Date :
January 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 27 2021
Estimated Enrollment :
7000 Patients enrolled
Trial Details
Trial ID
NCT04437992
Start Date
January 27 2020
End Date
April 27 2021
Last Update
July 24 2020
Active Locations (1)
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1
Regione Emilia Romagna
Bologna, Italy