MATERIALS AND METHODS
We conducted a prospective, multicenter, area-based cohort study of all the LP deliveries from December 1st 2013 to December 1st 2015 in Emilia Romagna, a region in Northern Italy with nearly 4.5 million people organized in 9 counties.
The study steering committee (consisting in 2 obstetricians, 2 neonatologists and 1 epidemiologist) defined the information to collect on pregnancies resulting in LP deliveries, and on neonates’ hospital course. Standardized chart abstraction forms were designed to obtain anonymized data on mothers (i.e maternal demographics, maternal medical and obstetrical complications, labor and delivery details) and their newborns (i.e birthweight, gender, Apgar scores, admission to the NICU or Intermediate/Step Down Unit, and length of stay, neonatal morbidities and mortality). In Emilia Romagna, inpatient obstetric and pediatric care was provided at that time by 28 hospitals within the National Health System. Recruitment occurred only at the 21 hospitals with at least 500 deliveries/year, equipped with NICUs or Intermediate/Step Down Units, that could care for LP infants: one obstetrician and one neonatologist/pediatrician from each study site approached mothers delivering at 34+0-36+6 weeks for written informed consent, and respectively completed the maternal and the neonatal data collection forms, as they interviewed the patients and consulted the medical records. Five trained research associates visited the study sites on a monthly basis to review the maternal and neonatal data collection forms with the physicians that had filled them. At the Data Managing Center (Modena Policlinico Hospital, University of Modena and Reggio Emilia) research associates used optical character recognition technology (Flexi Capture, Abbyy ®, Germany) to scan the data collection sheets, extract pertinent data, and organize it in a password protected database. If automated data extraction failed (approximately 5% of the times), research associates reviewed the forms and manually entered the missing data in the database. Approval from the Institution Review Board of the 9 Emilia Romagna Counties was obtained. The study was financed by the Emilia Romagna County Grent (n 417149 _ 2014).