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ZIKAlliance Pregnant Women Cohort

Pregnant Women (PW) Cohort for Evaluation of Risks of Congenital Malformations and Other Adverse Pregnancy Outcomes After Zika Virus Infection (Part of ZIKAlliance)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03188731
Acronym
ZIKAlliancePW
Enrollment
3852
Registered
2017-06-15
Start date
2017-05-24
Completion date
2021-09-30
Last updated
2022-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related, Zika Virus

Keywords

ZIKA, Dengue, Chikungunya, Pregnant Women, Pregnant Woman, ZIKV

Brief 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).

Interventions

None listed

Sponsors

European Union
CollaboratorOTHER
ZIKAlliance
CollaboratorUNKNOWN
Oswaldo Cruz Foundation
CollaboratorOTHER
University of Sao Paulo
CollaboratorOTHER
London School of Hygiene and Tropical Medicine
CollaboratorOTHER
Federal University of Bahia
CollaboratorOTHER
Universidade Federal de Goias
CollaboratorOTHER
University Medical Center Groningen
CollaboratorOTHER
University of Carabobo
CollaboratorOTHER
Universidad Industrial de Santander
CollaboratorOTHER
Sosecali Hospital, Guyaquil
CollaboratorUNKNOWN
Instituto de Medicina Tropical Pedro Kourí (IPK), Cuba
CollaboratorUNKNOWN
Mexican National Institute of Public Health
CollaboratorOTHER_GOV
Instituto Mexicano del Seguro Social
CollaboratorOTHER_GOV
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
Erasmus Medical Center
CollaboratorOTHER
University of Heidelberg Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* at least 16 years old * Pregnancy status confirmed * Within first or second trimester or first month of marked transmission season

Exclusion criteria

* Planing to leave area * Unable to attend follow-up visits * Unable to undergo venipuncture * Participates in another pregnant women study for ZIKA * Unable to consent without legal guardian

Design outcomes

Primary

MeasureTime frame
Congenital AbnormalitiesAt birth

Countries

Bolivia, Brazil, Colombia, Cuba, Guadeloupe, Mexico, Venezuela

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026