Risk Measurement of Perinatal and Neonatal Morbidity Characteristics and Applicability of GAIA Case Definitions: Results and Lessons Learnt of a Hospital-Based Prospective Cohort Study in the Valencia Region (2019–2020)

Antonio Carmona, María Latorre Tejerina, Alicia Martínez Sebastián, Dafina Dobreva, Cristina P. Jurca, Sergio Huerta Barberá, Vicente Bernat Montoya, Mercedes Aristoy Zabaleta, Ana Pineda Caplliure, Beatriz Mansilla Roig, María Navío Anaya, Ricardo Tosca-Segura, Miguel Tortajada-Girbés, Javier Díez-Domingo and Alejandro Orrico-Sánchez
Additional contact information
Antonio Carmona: Vaccines Research Department, Fundación Para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (Fisabio), Av. de Catalunya, 21, 46020 Valencia, Spain
María Latorre Tejerina: Department of Pediatrics, Hospital General Universitario de Castellón, Avinguda de Benicàssim, 128, 12004 Castelló de la Plana, Spain
Alicia Martínez Sebastián: Department of Pediatrics, Hospital Universitario Doctor Peset, Av. de Gaspar Aguilar, 90, 46017 Valencia, Spain
Dafina Dobreva: P95 Pharmacovigilance and Epidemiology, 3010 Leuven, Belgium
Cristina P. Jurca: Department of Pediatrics, Hospital General Universitario de Castellón, Avinguda de Benicàssim, 128, 12004 Castelló de la Plana, Spain
Sergio Huerta Barberá: Department of Pediatrics, Hospital General Universitario de Castellón, Avinguda de Benicàssim, 128, 12004 Castelló de la Plana, Spain
Vicente Bernat Montoya: Department of Pediatrics, Hospital General Universitario de Castellón, Avinguda de Benicàssim, 128, 12004 Castelló de la Plana, Spain
Mercedes Aristoy Zabaleta: Department of Pediatrics, Hospital General Universitario de Castellón, Avinguda de Benicàssim, 128, 12004 Castelló de la Plana, Spain
Ana Pineda Caplliure: Department of Pediatrics, Hospital Universitario Doctor Peset, Av. de Gaspar Aguilar, 90, 46017 Valencia, Spain
Beatriz Mansilla Roig: Department of Pediatrics, Hospital Universitario Doctor Peset, Av. de Gaspar Aguilar, 90, 46017 Valencia, Spain
María Navío Anaya: Department of Pediatrics, Hospital Universitario Doctor Peset, Av. de Gaspar Aguilar, 90, 46017 Valencia, Spain
Ricardo Tosca-Segura: Department of Pediatrics, Hospital General Universitario de Castellón, Avinguda de Benicàssim, 128, 12004 Castelló de la Plana, Spain
Miguel Tortajada-Girbés: Department of Pediatrics, Hospital Universitario Doctor Peset, Av. de Gaspar Aguilar, 90, 46017 Valencia, Spain
Javier Díez-Domingo: Vaccines Research Department, Fundación Para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (Fisabio), Av. de Catalunya, 21, 46020 Valencia, Spain
Alejandro Orrico-Sánchez: Vaccines Research Department, Fundación Para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (Fisabio), Av. de Catalunya, 21, 46020 Valencia, Spain

IJERPH, 2022, vol. 19, issue 12, 1-15

Abstract: Post-marketing safety surveillance of new vaccines aimed to be administered during pregnancy is crucial to orchestrate efficient adverse events evaluation. This is of special relevance in the current landscape of new vaccines being introduced in the pregnant women population, and particularly due to the recent administration of COVID-19 vaccines in pregnant women. This multi-center prospective cohort study, nested within the WHO-Global Vaccine Safety-MCC study, involved two hospitals in the Valencia region. Hereby, the incidence rates of seven perinatal and neonatal outcomes in the Valencia region are presented. The pooled data analysis of the two Valencian hospitals allowed the estimation of incidence rates in the Valencia Region (per 1000 live births): 86.7 for low birth weight, 78.2 for preterm birth, 58.8 for small for gestational age, 13 for congenital microcephaly, 0.4 for stillbirth, 1.2 for neonatal death and 6.5 for neonatal infection. These figures are in line with what is expected from a high-income country and the previously reported rates for Spain and Europe, except for the significantly increased rate for congenital microcephaly. Regarding the data for maternal immunization, the vaccination status was collected for 94.4% of the screened pregnant women, highlighting the high quality of the Valencian Vaccine Registry. The study also assessed the Valencian hospitals’ capacity for identifying and collecting data on maternal immunization status, as well as the applicability of the GAIA definitions to the identified outcomes.

Keywords: vaccination; pregnancy; maternal immunization; vaccine safety; standardized case definitions; incidence rates; neonatal outcomes (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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