Zika virus infection in pregnancy: a protocol for the joint analysis of the prospective cohort studies of the ZIKAlliance, ZikaPLAN and ZIKAction consortia

EC Zika Consortia Vertical Transmission Study Group, A E Ades, Elizabeth B Brickley, Neal Alexander, David Brown, Thomas Jaenisch, Demócrito de Barros Miranda-Filho, Moritz Pohl, Kerstin D Rosenberger, Antoni Soriano-Arandes, Claire Thorne, Ricardo Arraes de Alencar Ximenes, Thalia Velho Barreto de Araújo, Vivian I Avelino-Silva, Sarah Esperanza Bethencourt Castillo, Victor Hugo Borja Aburto, Patrícia Brasil, Celia D C Christie, Wayner Vieira de Souza, Jose Eduardo Gotuzzo HBruno Hoen, Marion Koopmans, Celina Maria Turchi Martelli, Mauro Martins Teixeira, Ernesto T A Marques, Maria Consuelo Miranda, Ulisses Ramos Montarroyos, Maria Elisabeth Moreira, J Glenn Morris, Barry Rockx, Paola Mariela Saba Villarroel, Carmen Soria Segarra, Adriana Tami, Marília Dalva Turchi, Carlo Giaquinto, Xavier de Lamballerie, Annelies Wilder-Smith, Philippe Mayaud

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    INTRODUCTION: Zika virus (ZIKV) infection in pregnancy has been associated with microcephaly and severe neurological damage to the fetus. Our aim is to document the risks of adverse pregnancy and birth outcomes and the prevalence of laboratory markers of congenital infection in deliveries to women experiencing ZIKV infection during pregnancy, using data from European Commission-funded prospective cohort studies in 20 centres in 11 countries across Latin America and the Caribbean.

    METHODS AND ANALYSIS: We will carry out a centre-by-centre analysis of the risks of adverse pregnancy and birth outcomes, comparing women with confirmed and suspected ZIKV infection in pregnancy to those with no evidence of infection in pregnancy. We will document the proportion of deliveries in which laboratory markers of congenital infection were present. Finally, we will investigate the associations of trimester of maternal infection in pregnancy, presence or absence of maternal symptoms of acute ZIKV infection and previous flavivirus infections with adverse outcomes and with markers of congenital infection. Centre-specific estimates will be pooled using a two-stage approach.

    ETHICS AND DISSEMINATION: Ethical approval was obtained at each centre. Findings will be presented at international conferences and published in peer-reviewed open access journals and discussed with local public health officials and representatives of the national Ministries of Health, Pan American Health Organization and WHO involved with ZIKV prevention and control activities.

    Original languageEnglish
    Article numbere035307
    Number of pages9
    JournalBMJ Open
    Issue number12
    Publication statusPublished - 15-Dec-2020

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