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).