Fetal growth restriction: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Preamble Need for developing case definitions and guidelines for data collection, analysis, and presentation for fetal growth restriction as an adverse event following immunization Fetuses that fail to meet their growth potential in utero are at risk for adverse antenatal and postnatal events such a...

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Bibliographic Details
Published in:Vaccine 2017-12, Vol.35 (48), p.6546-6554
Main Authors: Easter, Sarah Rae, Eckert, Linda O., Boghossian, Nansi, Spencer, Rebecca, Oteng-Ntim, Eugene, Ioannou, Christos, Patwardhan, Manasi, Harrison, Margo S., Khalil, Asma, Gravett, Michael, Goldenberg, Robert, McKelvey, Alastair, Gupta, Manish, Pool, Vitali, Robson, Stephen C., Joshi, Jyoti, Kochhar, Sonali, McElrath, Tom
Format: Article
Language:English
Subjects:
Adverse Drug Reaction Reporting Systems - standards
Age
Birth weight
Collaboration
Comorbidity
Congenital diseases
Data collection
Data Collection - standards
Data processing
Epidemiologic Methods
Epidemiology
Female
Fetal Growth Retardation - epidemiology
Fetuses
Gastrointestinal surgery
Health risk assessment
Humans
Immunization
Infant, Newborn
Infections
International organizations
Obstetrics
Pregnancy
Premature birth
Prenatal care
Prenatal development
Public health
Vaccination - adverse effects
Vaccines
Working groups
World Wide Web
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Summary:Preamble Need for developing case definitions and guidelines for data collection, analysis, and presentation for fetal growth restriction as an adverse event following immunization Fetuses that fail to meet their growth potential in utero are at risk for adverse antenatal and postnatal events such as stillbirth, preterm birth, and adverse neonatal and long-term health outcomes [1-5]. [...]antenatal recognition and monitoring of fetal growth restriction (FGR) is an important component of prenatal care [6-8]. [...]the Brighton case definition of FGR will focus on use of a combination of B-mode and Doppler ultrasound technology to establish the diagnosis of FGR. [...]to avoid selection bias, a restrictive time interval from immunization to onset of FGR should not be an integral part of such a definition. [...]we would like to acknowledge the Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project, funded by the Bill and Melinda Gates Foundation.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2017.01.042