ZIKAlliance Pregnant Women Cohort
ZIKAlliancePW
Pregnant Women (PW) Cohort for Evaluation of Risks of Congenital Malformations and Other Adverse Pregnancy Outcomes After Zika Virus Infection (Part of ZIKAlliance)
1 other identifier
observational
3,852
7 countries
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 24, 2017
CompletedFirst Submitted
Initial submission to the registry
June 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedMay 24, 2022
May 1, 2022
4.4 years
June 13, 2017
May 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Congenital Abnormalities
At birth
Study Arms (1)
Pregnant Women
Eligibility Criteria
Pregnant Women
You may qualify if:
- at least 16 years old
- Pregnancy status confirmed
- Within first or second trimester or first month of marked transmission season
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Heidelberg Medical Centerlead
- European Unioncollaborator
- ZIKAlliancecollaborator
- Oswaldo Cruz Foundationcollaborator
- University of Sao Paulocollaborator
- London School of Hygiene and Tropical Medicinecollaborator
- Federal University of Bahiacollaborator
- Universidade Federal de Goiascollaborator
- University Medical Center Groningencollaborator
- University of Carabobocollaborator
- Universidad Industrial de Santandercollaborator
- Sosecali Hospital, Guyaquilcollaborator
- Instituto de Medicina Tropical "Pedro Kourí (IPK), Cubacollaborator
- Mexican National Institute of Public Healthcollaborator
- Instituto Mexicano del Seguro Socialcollaborator
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- Erasmus Medical Centercollaborator
Study Sites (14)
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
Related Publications (1)
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.
PMID: 31878895DERIVED
Biospecimen
Blood, Hair, Urine, Vaginal fluids, Saliva, Semen
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Jänisch
University Hospital Heidelberg
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
June 13, 2017
First Posted
June 15, 2017
Study Start
May 24, 2017
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
May 24, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
1. The ZIKAlliance birth cohort is part of the 3 EC-funded Zika consortia. The data are intended to be shared after the individual cohort data is analyzed and published. 2. The ZIKAlliance birth cohort is part of the WHO-moderated IPD meta-analysis Consortium. The data are intended to be shared after the individual cohort data is analyzed and published.