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Multicenter Study
. 2022 Jun 10;19(12):7132.
doi: 10.3390/ijerph19127132.

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  1 , María Latorre Tejerina  2 , Alicia Martínez Sebastián  3 , Dafina Dobreva  4 , Cristina P Jurca  2 , Sergio Huerta Barberá  2 , Vicente Bernat Montoya  2 , Mercedes Aristoy Zabaleta  2 , Ana Pineda Caplliure  3 , Beatriz Mansilla Roig  3 , María Navío Anaya  3 , Ricardo Tosca-Segura  2 , Miguel Tortajada-Girbés  3 , Javier Díez-Domingo  1   5 , Alejandro Orrico-Sánchez  1   5
Affiliations
Multicenter Study

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 et al. Int J Environ Res Public Health. .

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: incidence rates; maternal immunization; neonatal outcomes; pregnancy; standardized case definitions; vaccination; vaccine safety.

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Conflict of interest statement

A.O. has attended several conferences whose registration, travel and accommodation costs have been covered by pharmaceutical companies. A.O. and his institution received research grants to develop observational studies and clinical trials from SP, GSK and MSD related to the vaccines. A.O. also acted as advisor for SP, GSK and MSD for other vaccines. J.D. has received research grants from SP, GSK, Seqirus. J.D. has been a principal investigator in clinical trials with influenza vaccine for GSK, SP, ABBOT, and has acted as an advisor for SP and MSD. Member of Monitoring committee of clinical trials for Janssen and GSK. The rest of the authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1
Figure 1
Geographic situation and characteristics of the two participant hospitals in the Valencia Region (Hospital General de Castellón and Hospital Universitario Dr. Peset): facility ownership, catchment population, number of beds, and presence of a neonate intensive care unit (NICU).
Figure 2
Figure 2
Incidence rates (per 1000 live births) for the different perinatal and neonatal outcomes identified, per study site and overall for the Valencia Region.
Figure 3
Figure 3
Percentage of classification of the cases recruited in Valencia into any of the diagnostic certainty levels of the GAIA definitions, per neonatal outcome of interest.
Figure 4
Figure 4
Maternal immunization: Bar chart showing the percentage of the vaccinated mothers from recruited cases classified by GAIA level of diagnostic certainty.
Figure 5
Figure 5
Comparative on the incidence rates of neonatal outcomes estimated in the Valencian study versus rates reported in previous literature for Spain and Europe overall. Previously reported rates for SGA in Spain are not available. Previously reported rate of LBW for Europe is an average of the rates reported by the UN, WHO, and UNICEF [13].
See this image and copyright information in PMC

References

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