A Pilot Study for Implementation of First Trimester Screening of Aneuploidies in Campania Region (PISTA)
Aneuploidy
About this trial
This is an interventional screening trial for Aneuploidy focused on measuring aneuploidy, screening, combined test, non invasive prenatal testing
Eligibility Criteria
Inclusion Criteria: all patients referred to our hospital for first trimester screening scan Exclusion Criteria: maternal age<18 twin pregnancies lack of a signed consent form
Sites / Locations
- University Federico IIRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Group A: NT+ NIPT
Group B
Group A patients will undergo NT between 11+3 and 13+6 weeks. If the NT is <3.5 mm, the patient will be offered to continue the screening with NIPT. If NIPT comes back as positive result, the result will be confirmed by an invasive procedure (amniocentesis/villocentesis); if, on the other hand, the NIPT will give a negative result, the screening is concluded and the patient will not undergo further tests.
Combined test + NIPT (n=200) The patients of group A will undergo NT between 11+3 and 13+6 weeks, according to the same protocol foreseen for Group A. If the NT is <3.5 mm, the patient will be offered continuation of the screening using the combined test. In case of: High risk (1:2-1:100), the patient will be offered an invasive procedure (amniocentesis/villocentesis) Intermediate risk (1:101-1:1000), the patient will be offered NIPT, according to the protocol already described for Group A. In the event of a positive result, the patient will undergo an invasive procedure (amniocentesis/villocentesis ); in the case of negative NIPT, the screening is concluded and the patient will not undergo further tests. Low risk (>1:1000), screening ends and the patient will not undergo further tests.