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.