Study design
Multicenter prospective observational cohort study coordinated by V. Buzzi” Children Hospital, Milan (Coordination Unit), and involving the following 20 Italian maternity units: “L. Sacco” University Hospital, Asst-Fbf-Sacco, Milan; “M.Melloni” University Hospital Asst-Fbf-Sacco, Milan; S.Pio X, Humanitas University Hospital, Milan; “Careggi” University Hospital, Florence; “Santa Maria della Misericordia” University Hospital, Perugia; “Sant’Anna” University Hospital, Torino; Modena Polyclinic University Hospital, Modena; “G. Martino” University Hospital, Messina; “San Matteo” Hospital, Pavia; “Arcispedale Sant’Anna” University Hospital, Ferrara; “V. Emanuele” University Hospital, Catania; “Cisanello” University Hospital, Pisa; “Gemelli” University Hospital, Rome; “Ospedali Riuniti” University Hospital, Foggia; Verona Polyclinic University Hospital, Verona; Bari Polyclinic University Hospital, Bari; “Vanvitelli” University Hospital, Naples; “Federico II” University Hospital, Naples; San Salvatore University Hospital, L’Aquila.
Each participating center has access to a database and all patients are prospectively registered by trained operators.
After the study protocol presentation in January 2021, a monthly newsletter with regular update on the research status and recruitment is sent to all centers. The Coordination Unit will monitor the case reporting and completeness of data collection for all the participating centers on a monthly basis. The final statistical analyses will be performed by the Coordination Unit.