Abstract

Zika en Embarazadas y Niños (ZEN) is a prospective cohort study designed to identify risk factors and modifiers for Zika virus (ZIKV) infection in pregnant women, partners, and infants, as well as to assess the risk for adverse maternal, fetal, infant, and childhood outcomes of ZIKV and other congenital infections. ZIKV infection during pregnancy may be associated with long-term sequelae. In the ZEN cohort, 1,519 pregnant women and 287 partners were enrolled from 3 departments within Colombia between February 2017 and January 2018, as well as 1,108 infants born to the pregnant women who were followed to 6 months. The data include baseline questionnaires at enrollment; repeated symptoms and study follow-up questionnaires; the results of lab tests to detect ZIKV and other congenital infections; medical record abstractions; infant physical, eye, and hearing exams; and developmental screening tests. Follow-up of 850 mother-child dyads occurred at 9 months, 12 months, and 18 months with developmental screenings, physical exams, and parent questionnaires. The data will be pooled with those from other prospective cohort studies for an individual participant data meta-analysis of ZIKV infection during pregnancy to characterize pregnancy outcomes and sequelae in children.

Highlights

  • Zika virus (ZIKV) is transmitted primarily through the bite of an infected Aedes species mosquito; it can be transmitted between sexual partners or from mother-to-child in utero or during delivery [1,2]

  • Key knowledge gaps still exist, such as understanding the full spectrum of adverse outcomes in pregnant women, fetuses, and infants associated with ZIKV infection in pregnancy; the relative contributions of sexual transmission and mosquito-borne transmission to the occurrence of infections in pregnancy; and the risk of adverse fetal and infant outcomes by gestational week of maternal infection or presence of ZIKV symptoms

  • Limited evidence suggests that ZIKV infection during pregnancy may be associated with long-term sequelae, including poor neurodevelopmental outcomes for those without congenital abnormalities [8,9,10,11,12,13]; the lack of an adequate comparison group in existing analyses limits the interpretation of whether these adverse outcomes can be attributed to ZIKV infection

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Summary

INTRODUCTION

Zika virus (ZIKV) is transmitted primarily through the bite of an infected Aedes species mosquito; it can be transmitted between sexual partners or from mother-to-child in utero or during delivery [1,2]. Numerous studies have documented the serious consequences of ZIKV infection during pregnancy, in- Key knowledge gaps still exist, such as understanding the full spectrum of adverse outcomes in pregnant women, fetuses, and infants associated with ZIKV infection in pregnancy; the relative contributions of sexual transmission and mosquito-borne transmission to the occurrence of infections in pregnancy; and the risk of adverse fetal and infant outcomes by gestational week of maternal infection or presence of ZIKV symptoms. The primary objectives were to: (1) identify risk factors for ZIKV infection in pregnant women, partners, and infants; (2) assess the risk for adverse maternal, fetal, infant, and childhood outcomes associated with ZIKV infection and other congenital infections; and (3) assess modifiers of risk

STUDY PARTICIPANTS
Ethics statement
KEY FINDINGS
Findings
STRENGTHS AND LIMITATIONS
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