Zika in Infants and Pregnancy (ZIP)

Summary

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.

Conditions

• Zika Virus Disease (Disorder)

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• National Institute of Environmental Health Sciences (NIEHS)

  collaborator NIH

• Oswaldo Cruz Foundation

  collaborator OTHER

• RTI International

  lead OTHER

Principal Investigators

• Ricardo Ximenes, MD · Departamento de Medicina Tropical da Universidade Federal de Pernambuco-UFPE

• William Britt, MD · University of Alabama Birmingham School of Medicine

• Marisa Mussi, MD · Ribeirão Preto Medical School, University of São Paulo

• Albert Ko, MD · Yale University, Laboratory of Epidemiology and Public Health

• Deolinda Scalabrin · Centro de Pesquisas Gonçalo Moniz, Fundação Oswaldo Cruz/MS

• Marisa Elisabeth Lopes · Instituto Fernandes Figueira - FIOCRUZ

• Ana Garces, MD · Fundación para la Alimentación y Nutrición de Centro América y Panamá (INCAP)

• Jose Cordero, MD · University of Georgia

• Carmen Milagros Velez Vega, PhD · University of Puerto Rico

• George Seage, MD · Harvard University School of Public Health

• Carmen Zorilla, MD · University of Puerto Rico

• Eva Harris, PhD · University of Californina Berkeley

• Angel Balmaseda · MINSA Central

• Juan F Arias, MD · St. Jude Children's Research Hospital

• Jill Lebov, PhD · RTI International

• Teresa Ochoa Woodell, PhD · Universidad Peruana Cayetano Heredia

Eligibility

Min Age

15 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2020-05-05

Completion

2020-05-05

Countries

• Brazil
• Colombia
• Guatemala
• Nicaragua
• Peru
• Puerto Rico

Study Locations