ZIKAlliance Pregnant Women Cohort
Condition: Zika Virus; Pregnancy Related
MeSH terms: Zika Virus Infection
Study type: Observational

Summary: 
      The aim of this proposal is to evaluate the causal relationship between Zika virus (ZIKV)
      infections in pregnancy and congenital malformations. We will estimate the absolute and
      relative risks of congenital malformations and other adverse outcomes of pregnancy among
      women who become infected with ZIKV during pregnancy compared to uninfected pregnant women,
      also leading to further validation of the Congenital Zika Syndrome.
    

Detailed description: 
      The aim of this proposal is to evaluate the causal relationship between Zika virus (ZIKV)
      infections in pregnancy and congenital malformations. We will estimate the absolute and
      relative risks of congenital malformations and other adverse outcomes of pregnancy among
      women who become infected with ZIKV during pregnancy compared to uninfected pregnant women,
      also leading to further validation of the Congenital Zika Syndrome.

      We will also determine the ZIKV maternal to child transmission rate and evaluate co-factors
      or effect modifiers that account for the large variability seen in the preliminary absolute
      risk estimates derived from population figures and reporting of microcephaly in different
      states in Brazil and across Latin America.

      We will carry out a pregnant women (PW) multicentre cohort study in areas across Latin
      America and the Caribbean. Women will be enrolled early in pregnancy and followed every 4
      weeks, in connection with their routine antenatal care visits. At each visit, urine and blood
      samples will be collected, tested and stored.

      Among PW reporting recent or current undifferentiated fever/rash syndrome at any point in
      time, the acute illness episode will be characterized in greater detail. PW with suspected
      ZIKV infection (i.e. meeting the Pan American Health Organization (PAHO) clinical case
      definition) during pregnancy will be managed according to national protocols. Irrespective of
      symptoms, pregnant women will be followed prospectively and revisited at birth (or after
      abortion) for a detailed documentation of the outcome of their pregnancy.

      Live newborns will receive a detailed neonatal examination. In the course of examination of
      the newborns, biological samples will be collected and stored. Other potential causes of
      congenital abnormalities (TORCHS infections in the mother, toxic substances, chromosomal
      abnormalities), and potential effect modifiers (for example past flavivirus
      infections/vaccinations, socio-economic status) will also be assessed.

      With appropriate counselling and consent, biological samples of newborns with severe
      abnormalities, deceased newborns, stillborn babies, and aborted foetuses from ZIKV-infected
      mothers will be collected to help elucidate the aetiological contribution of ZIKV in
      neurological and other congenital malformations.

      Children of women infected with ZIKV during pregnancy - and a subset of the children born to
      uninfected women - will be followed prospectively after birth for the assessment of
      neuro-developmental milestones (separate protocol).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant Women
      
Biospecimen description: 
      Blood, Hair, Urine, Vaginal fluids, Saliva, Semen
    
Keywords: ZIKA; Dengue; Chikungunya; Pregnant Women; Pregnant Woman; ZIKV