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A Pilot Study for Implementation of First Trimester Screening of Aneuploidies in Campania Region (PISTA)

NCT05798858 NA UNKNOWN

The study aims to compare two different protocols for first trimester screening of aneuploidies, one based on nuchal translucency and NIPT and another one based on the integration between combined test and NIPT, in order to identify which is the most adequate for the Campania region. In particular, a cost-benefit comparison will be made which will take into account for each method: * Actual costs; * Percentage of patients who agree to undergo the proposed screening and number of patients who undergo extra tests not included in the screening protocol; * Post-invasive procedure miscarriage rate; * False positives (fetuses undergoing an invasive procedure for a positive screen, which have a normal karyotype).

Details

Lead sponsorFederico II University
PhaseNA
StatusUNKNOWN
Enrolment400
Start dateTue Jan 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionFri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

Italy