The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The study will prospectively enroll a cohort of pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test. The study will follow these women through their pregnancy to identify for clinical evidence of acute ZIKV, while controlling for potential confounders. Outcomes in the women, the developing fetus, and infants will be assessed. All protocol-specified data will be recorded and entered in a central data management system for the purposes of analysis of composite data from the study.
The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The study will prospectively enroll a cohort of pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test. The study will follow these women through their pregnancy to identify for clinical evidence of acute ZIKV, while controlling for potential confounders. Outcomes in the women, the developing fetus, and infants will be assessed. All protocol-specified data will be recorded and entered in a central data management system for the purposes of analysis of composite data from the study. The study will recruit up to10,000 pregnant women in their first trimester from ZIKV-endemic regions and follow them longitudinally to study the impact of incident ZIKV during pregnancy on maternal, fetal, and newborn outcomes. Researchers will identify cases of incident ZIKV among pregnant women by monitoring for symptoms of Zika-like illness and performing serial laboratory sampling for diagnosis of seroconversion and viral shedding. After delivery, infants born with evidence of ZIKV or born to mothers diagnosed with incident virus infection will be followed in a prospective longitudinal cohort for at least 1 year. In addition, a control group of infants born to mothers without evidence of ZIKV during pregnancy will be followed.
Study Type
OBSERVATIONAL
Enrollment
6,461
Centro de Pesquisas Gonçalo Moniz, Fundação Oswaldo Cruz/MS; Rue Waldemar Falcao
Salvador, Estado de Bahia, Brazil
Departamento de Medicina Tropical da Universidade Federal de Pernambuco-UFPE
Recife, Pernambuco, Brazil
Instituto Fernandes Figueira - FIOCRUZ
Rio de Janeiro, Rio de Janeiro, Brazil
Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes, 3900 - Monte Alegre
Ribeirão Preto, São Paulo, Brazil
Centro Medico Imbanaco
Cali, Colombia
Fundación para la Alimentación y Nutrición de Centro América y Panamá (INCAP)
Guatemala City, Guatemala
MINSA Central
Managua, Nicaragua
Universidad Peruana
Lima, Peru
University of Puerto Rico Medical Sciences Campus
San Juan, Puerto Rico
University of Puerto Rico - Recinto de Río Piedras
San Juan, Puerto Rico
Incidence of congenital malformations for ZIKV infected participants
To measure the incidence of congenital malformations in fetuses/infants.
Time frame: Time of birth of infant
Incidence of congenital malformations for ZIKV infected participants
To measure the incidence of congenital malformations in fetuses/infants.
Time frame: 3 months of age
Incidence of congenital malformations for ZIKV infected participants
To measure the incidence of congenital malformations in fetuses/infants.
Time frame: 6 months of age
Incidence of congenital malformations for ZIKV infected participants
To measure the incidence of congenital malformations in fetuses/infants.
Time frame: 12 months of age
Incidence of adverse fetal outcomes for ZIKV infected participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Time frame: Time of birth of infant
Incidence of adverse fetal outcomes for ZIKV infected participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Time frame: 3 months of age
Incidence of adverse fetal outcomes for ZIKV infected participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Time frame: 6 months of age
Incidence of adverse fetal outcomes for ZIKV infected participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Time frame: 12 months of age
Incidence of congenital malformations for ZIKV symptomatic participants
To measure the incidence of congenital malformations in fetuses/infants.
Time frame: Time of birth of infant
Incidence of congenital malformations for ZIKV symptomatic participants
To measure the incidence of congenital malformations in fetuses/infants.
Time frame: 3 months of age
Incidence of congenital malformations for ZIKV symptomatic participants
To measure the incidence of congenital malformations in fetuses/infants.
Time frame: 6 months of age
Incidence of congenital malformations for ZIKV symptomatic participants
To measure the incidence of congenital malformations in fetuses/infants.
Time frame: 12 months of age
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Time frame: Time of birth of infant
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Time frame: 3 months of age
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Time frame: 6 months of age
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Time frame: 12 months of age
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.