Feasibility Study of a New Screening Program for Major Aneuploidies (T21 T18 T13) in the Emilia-Romagna Region (SAPERER)

  • STATUS
    Recruiting
  • participants needed
    7000
  • sponsor
    Azienda Usl di Bologna
Updated on 19 February 2024

Summary

The study is promoted by the Emilia Romagna Region which identified in the Bologna AUSL the coordinating center (Unit Operativa Complessa Laboratorio Unico Metropolitano, LUM, Maggiore Hospital). The medical genetics centers, participating in the technical-scientific coordination group of assessment (resolution No. 1894, 4/11/2019), the family counseling centers and the region prenatal hospital clinics are involved as collaborative experimental centers.

Currently, 14,400 combined tests are carried out in the Emilia Romagna Region every year.

As a result offering the new non-invasive NIPT test, it is estimated that the number of participants in the screening program will increase by up to 20,000/year.

The study will collect data on the women who will access the combined test in the first 9 months of the protocol and join the enrollment.

Details
Condition Autosomal Aneuploidy
Age 18years - 100years
Treatment NIPT
Clinical Study IdentifierNCT04437992
SponsorAzienda Usl di Bologna
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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