Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3852 participants
OBSERVATIONAL
2017-05-24
2021-09-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant Women
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Pregnancy status confirmed
* Within first or second trimester or first month of marked transmission season
Exclusion Criteria
* Unable to attend follow-up visits
* Unable to undergo venipuncture
* Participates in another pregnant women study for ZIKA
* Unable to consent without legal guardian
16 Years
45 Years
FEMALE
Yes
Sponsors
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European Union
OTHER
ZIKAlliance
UNKNOWN
Oswaldo Cruz Foundation
OTHER
University of Sao Paulo
OTHER
London School of Hygiene and Tropical Medicine
OTHER
Federal University of Bahia
OTHER
Universidade Federal de Goias
OTHER
University Medical Center Groningen
OTHER
University of Carabobo
OTHER
Universidad Industrial de Santander
OTHER
Sosecali Hospital, Guyaquil
UNKNOWN
Instituto de Medicina Tropical "Pedro Kourí (IPK), Cuba
UNKNOWN
Mexican National Institute of Public Health
OTHER_GOV
Instituto Mexicano del Seguro Social
OTHER_GOV
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Erasmus Medical Center
OTHER
University of Heidelberg Medical Center
OTHER
Responsible Party
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Thomas Jaenisch
Senior Scientist
Principal Investigators
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Thomas Jänisch
Role: PRINCIPAL_INVESTIGATOR
University Hospital Heidelberg
Locations
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Sosecali Ltd. (SOSE)
Guaqui, , Bolivia
INSERM
Santa Cruz, , Bolivia
Federal University of Bahia (UFB)
Bahia, , Brazil
Universidade Federal de Minas Gerais
Belo Horizonte, , Brazil
Federal University of Goias
Goiás, , Brazil
Fundacao Oswaldo Cruz (FIOCRUZ)
Recife, , Brazil
Fundacao Oswaldo Cruz (FIOCRUZ)
Rio de Janeiro, , Brazil
University of Sao Paulo
São Paulo, , Brazil
Industrial University of Santander (UIS)
Bucaramanga, , Colombia
Pedro Kouri Institute (IPK)
Havana, , Cuba
INSERM
Pointe-à-Pitre, , Guadeloupe
IMSS Mexico (IMSS)
Guadalajara, , Mexico
National Institute of Public Health (INSP)
Mérida, , Mexico
Universidad de Carabobo / UMC Groningen (UMCG)
Valencia, , Venezuela
Countries
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References
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Avelino-Silva VI, Mayaud P, Tami A, Miranda MC, Rosenberger KD, Alexander N, Nacul L, Segurado A, Pohl M, Bethencourt S, Villar LA, Viana IFT, Rabello R, Soria C, Salgado SP, Gotuzzo E, Guzman MG, Martinez PA, Lopez-Gatell H, Hegewisch-Taylor J, Borja-Aburto VH, Gonzalez C, Netto EM, Saba Villarroel PM, Hoen B, Brasil P, Marques ETA, Rockx B, Koopmans M, de Lamballerie X, Jaenisch T; ZIKAlliance Clinical Study Group. Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean: the ZIKAlliance consortium. BMC Infect Dis. 2019 Dec 26;19(1):1081. doi: 10.1186/s12879-019-4685-9.
Other Identifiers
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734548PW (EC | H2020 | RIA)
Identifier Type: -
Identifier Source: org_study_id
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