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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2021

Open Access 01-12-2021 | Research article

Maternal and neonatal data collection systems in low- and middle-income countries for maternal vaccines active safety surveillance systems: A scoping review

Authors: Mabel Berrueta, Agustin Ciapponi, Ariel Bardach, Federico Rodriguez Cairoli, Fabricio J. Castellano, Xu Xiong, Andy Stergachis, Sabra Zaraa, Ajoke Sobanjo-ter Meulen, Pierre Buekens, Scoping Review Collaboration Group

Published in: BMC Pregnancy and Childbirth | Issue 1/2021

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Abstract

Background

Most post-licensure vaccine pharmacovigilance in low- and middle-income countries (LMICs) are passive reporting systems. These have limited utility for maternal immunization pharmacovigilance in LMIC settings and need to be supplemented with active surveillance. Our study’s main objective was to identify existing perinatal data collection systems in LMICs that collect individual information on maternal and neonatal health outcomes and could be developed to inform active safety surveillance of novel vaccines for use during pregnancy.

Methods

A scoping review was performed following the Arksey and O’Malley six-stage approach. We included studies describing electronic or mixed paper-electronic data collection systems in LMICs, including research networks, electronic medical records, and custom software platforms for health information systems. Medline PubMed, EMBASE, Global Health, Cochrane Library, LILACS, Bibliography of Asian Studies (BAS), and CINAHL were searched through August 2019. We also searched grey literature including through Google and websites of existing relevant perinatal data collection systems, as well as contacted authors of key studies and experts in the field to validate the information and identify additional sources of relevant unpublished information.

Results

A total of 11,817 records were identified. The full texts of 264 records describing 96 data collection systems were assessed for eligibility. Eight perinatal data collection systems met our inclusion criteria: Global Network’s Maternal Newborn Health Registry, International Network for the Demographic Evaluation of Populations and their Health; Perinatal Informatic System; Pregnancy Exposure Registry & Birth Defects Surveillance; SmartCare; Open Medical Record System; Open Smart Register Platform and District Health Information Software 2. These selected systems were qualitatively characterized according to seven different domains: governance; system design; system management; data management; data sources, outcomes and data quality.

Conclusion

This review provides a list of active maternal and neonatal data collection systems in LMICs and their characteristics as well as their outreach, strengths, and limitations. Findings could potentially help further understand where to obtain population-based high-quality information on outcomes to inform the conduct of maternal immunization active vaccine safety surveillance activities and research in LMICs.
Appendix
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Metadata
Title
Maternal and neonatal data collection systems in low- and middle-income countries for maternal vaccines active safety surveillance systems: A scoping review
Authors
Mabel Berrueta
Agustin Ciapponi
Ariel Bardach
Federico Rodriguez Cairoli
Fabricio J. Castellano
Xu Xiong
Andy Stergachis
Sabra Zaraa
Ajoke Sobanjo-ter Meulen
Pierre Buekens
Scoping Review Collaboration Group
Publication date
01-12-2021
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2021
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-021-03686-9

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