WHO global vaccine safety multi-country collaboration project on safety in pregnancy: Assessing the level of diagnostic certainty using standardized case definitions for perinatal and neonatal outcomes and maternal immunization

Stuurman, Anke L.; Sharan, Apoorva; Jahagirdar, Shubhashri; Elango, Varalakshmi; Riera-Montes, Margarita; Kashyap, Neeraj; Biccler, Jorne; Poluru, Ramesh; Arora, Narendra K.; Mathai, Matthews; Mangtani, Punam; Devlieger, Hugo; Anderson, Steven A.; Whitaker, Barbee I.; Wong, Hui-Lee; Cutland, Clare; Maure, Christine; Sites, Who Gvs Mcc

doi:10.1016/j.jvacx.2021.100123

Cited by 6 publications

(27 citation statements)

References 21 publications

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“…The results showed that the case definitions for PTB, LBW, ND, and NI were generally applicable for all the recruited cases, whereas those for SB, CM, and SGA had limited applicability ( Figure 3 ). These findings are in line with the results obtained in the global WHO-GVS-MCC study [ 9 , 10 ].…”

Section: Discussionsupporting

confidence: 92%

“…The outcomes were selected based on relevance and perceived complexity of data collection. The variables of interest for this study were defined as follows [ 9 , 10 ]: Low birth weight (LBW): first weight of <2500 g recorded in the birth register or patient record. Preterm birth (PTB): reported gestational age (GA) of < 37 weeks.…”

Section: Methodsmentioning

confidence: 99%

“…Up to 100 cases per outcome were systematically recruited at each site [ 9 , 10 ]. For each recruited case, case report forms (CRFs) were completed from a variety of sources, including the mother’s antenatal care records, the antenatal care card, and patient records.…”

Section: Methodsmentioning

confidence: 99%

“…In response to the call of WHO for a globally concerted approach to monitoring the safety of vaccines in pregnancy, the Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project was launched in 2015 [ 2 , 7 , 8 ] with the objective of establishing standardized definitions for obstetric and neonatal outcomes to increase the comparability of safety data across research studies and surveillance systems. In the present study, we will also assess the applicability of GAIA case definitions to our recruited cases, in order to inform future vaccine safety studies and provide a gold-standard reference for the implementation of these definitions in the LMIC countries as part of the WHO-GVS-MCC study [ 6 , 7 , 8 , 9 , 10 ].…”

Section: Introductionmentioning

confidence: 99%

“…This multi-center prospective descriptive cohort study, nested within the WHO-GVS-MCC study [ 9 , 10 , 11 ], involved two hospitals from the Valencia region. Spain was the only high-income country represented in the WHO-GVS-MCC study, serving as a reference to LMICs in terms of risk measurement of early childhood outcomes and applicability of specific neonatal outcomes case definitions.…”

Section: Introductionmentioning

confidence: 99%

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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)

Carmona

Tejerina

Sebastián

et al. 2022

IJERPH

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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.

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Section: Discussionsupporting

confidence: 92%