Chorioamnionitis: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

• Published in: Vaccine Vol. 37; no. 52; pp. 7610 - 7622
• Main Authors: Kachikis, Alisa, Eckert, Linda O., Walker, Christie, Bardají, Azucena, Varricchio, Frederick, Lipkind, Heather S., Diouf, Khady, Huang, Wan-Ting, Mataya, Ronald, Bittaye, Mustapha, Cutland, Clare, Boghossian, Nansi S., Mallett Moore, Tamala, McCall, Rebecca, King, Jay, Mundle, Shuchita, Munoz, Flor M., Rouse, Caroline, Gravett, Michael, Katikaneni, Lakshmi, Ault, Kevin, Klein, Nicola P., Roberts, Drucilla J., Kochhar, Sonali, Chescheir, Nancy
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 10.12.2019; Elsevier Limited; Elsevier; Elsevier Science
• Subjects: Adverse event; Amnionitis; Bacterial infections; Bacterial Infections - prevention & control; Cardiac arrhythmia; Case definition; Chorioamnionitis; Chorioamnionitis - chemically induced; Chorioamnionitis - microbiology; Clinical trials; Collaboration; Data analysis; Data collection; Data Collection - standards; Embaràs; Etiology; Female; Guidelines; Humans; Immunization; Immunization - adverse effects; Infections; Inflammation; Intra-amniotic infection; Laboratories; Malalties de la placenta; Membranes; Morbidity; Mortality; Pathogenesis; Pathogens; Pertussis; Placenta; Placenta diseases; Practice Guidelines as Topic; Pregnancy; Public health; Risk Factors; Sepsis; Surveillance; Surveillance systems; Vaccines; Websites; Intra-amniotic infection; Immunization; Chorioamnionitis; Case definition; Adverse event; Amnionitis; Guidelines
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2019.05.030

[...]in 2015, Datwani et al published their review of the Vaccine Adverse Event Reporting System (VAERS) database to explore reports of chorioamnionitis after receipt of any vaccine in the United States between 1990 and 2014. Most countries recommend acellular pertussis routinely during pregnancy, while WHO recommends the acellular pertussis vaccine specifically in areas of high disease burden [38–41].1.2 Methods for the development of the case definition and guidelines for data collection, analysis, and presentation for chorioamnionitis as an adverse event following immunization Due to the lack of a clear definition for chorioamnionitis to facilitate data comparability across trials and surveillance systems, and following the process described in the GAIA overview paper [42] as well as on the Brighton Collaboration Website, https://www.brightoncollaboration.org/about-us/vision-and-mission.html, the Brighton Collaboration Chorioamnionitis Working Group was formed in 2018 and included members from clinical, academic, public health, and industry backgrounds. [...]a clinically severe event may appropriately be classified as Level 2 or 3 rather than Level 1 if it could reasonably be of non-chorioamnionitis etiology. [...]to avoid selection bias, a restrictive time interval from immunization to onset of chorioamnionitis should not be an integral part of such a definition.