Zika in Infants and Pregnancy (ZIP)

August 12, 2021 updated by: RTI International

International Prospective Observational Cohort Study of Zika in Infants

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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 (Actual)

6461

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40296-710
        • Centro de Pesquisas Gonçalo Moniz, Fundação Oswaldo Cruz/MS; Rue Waldemar Falcao
    • PE
      • Recife, PE, Brazil, CEP: 50670-901
        • Departamento de Medicina Tropical da Universidade Federal de Pernambuco-UFPE
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22250-020
        • Instituto Fernandes Figueira - FIOCRUZ
    • SP
      • Ribeirão Preto, SP, Brazil, 14049-900
        • Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes, 3900 - Monte Alegre
  • Colombia
      • Cali, Colombia
        • Centro Médico Imbanaco
  • Guatemala
      • Guatemala, Guatemala
        • Fundación para la Alimentación y Nutrición de Centro América y Panamá (INCAP)
  • Nicaragua
      • Managua, Nicaragua, 16064
        • MINSA Central
  • Peru
      • Lima, Peru
        • Universidad Peruana
  • Puerto Rico
      • San Juan, Puerto Rico, 00921
        • University of Puerto Rico Medical Sciences Campus
      • San Juan, Puerto Rico, 00936
        • University of Puerto Rico - Recinto de Río Piedras

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The study will recruit up to 10,000 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 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.

Description

Inclusion Criteria:

  • Informed consent
  • Age >15 years
  • Assent and consent as required per local country regulations
  • Confirmation of pregnancy by beta human chorionic gonadotropin (hCG) measurement in blood/urine or ultrasound confirmation of pregnancy with fetal heart tones present
  • 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.

Exclusion Criteria: Pregnant Women

  • Women who cannot adhere to proposed testing schedule
  • Pregnant women enrolled in other research including other ZIKV research

Inclusion Criteria (newborn)

  • All infants born to women enrolled in the observational cohort are eligible for enrollment

Exclusion Criteria (newborn)

  • Mother or custodial parent does not consent to have child participate
  • Infants born to mothers that are not part of the ZIP cohort study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ZIKV infected women
The study will prospectively enroll pregnant women up to 17 weeks and 6 days gestation and follow them through their pregnancy for clinical evidence of acute ZIKV infection while controlling for potential confounders. All pregnant women will be followed throughout the pregnancy, delivery, and 6 weeks postpartum. Outcomes in women, the developing fetus, and infants will be assessed.
Control (uninfected women)
The women who remain uninfected will serve as the internal comparison group. The infants who remain uninfected at delivery and throughout the follow-up period will serve as the internal comparison group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of congenital malformations for ZIKV infected participants
Time Frame: Time of birth of infant
To measure the incidence of congenital malformations in fetuses/infants.
Time of birth of infant
Incidence of congenital malformations for ZIKV infected participants
Time Frame: 3 months of age
To measure the incidence of congenital malformations in fetuses/infants.
3 months of age
Incidence of congenital malformations for ZIKV infected participants
Time Frame: 6 months of age
To measure the incidence of congenital malformations in fetuses/infants.
6 months of age
Incidence of congenital malformations for ZIKV infected participants
Time Frame: 12 months of age
To measure the incidence of congenital malformations in fetuses/infants.
12 months of age
Incidence of adverse fetal outcomes for ZIKV infected participants
Time Frame: Time of birth of infant
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 of birth of infant
Incidence of adverse fetal outcomes for ZIKV infected participants
Time Frame: 3 months of age
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.
3 months of age
Incidence of adverse fetal outcomes for ZIKV infected participants
Time Frame: 6 months of age
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.
6 months of age
Incidence of adverse fetal outcomes for ZIKV infected participants
Time Frame: 12 months of age
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.
12 months of age
Incidence of congenital malformations for ZIKV symptomatic participants
Time Frame: Time of birth of infant
To measure the incidence of congenital malformations in fetuses/infants.
Time of birth of infant
Incidence of congenital malformations for ZIKV symptomatic participants
Time Frame: 3 months of age
To measure the incidence of congenital malformations in fetuses/infants.
3 months of age
Incidence of congenital malformations for ZIKV symptomatic participants
Time Frame: 6 months of age
To measure the incidence of congenital malformations in fetuses/infants.
6 months of age
Incidence of congenital malformations for ZIKV symptomatic participants
Time Frame: 12 months of age
To measure the incidence of congenital malformations in fetuses/infants.
12 months of age
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
Time Frame: Time of birth of infant
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Time of birth of infant
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
Time Frame: 3 months of age
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
3 months of age
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
Time Frame: 6 months of age
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
6 months of age
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
Time Frame: 12 months of age
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
12 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RTI International

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Oswaldo Cruz Foundation
National Institute of Environmental Health Sciences (NIEHS)

Investigators

  • Principal Investigator: Ricardo Ximenes, MD, Departamento de Medicina Tropical da Universidade Federal de Pernambuco-UFPE
  • Principal Investigator: William Britt, MD, University of Alabama Birmingham School of Medicine
  • Principal Investigator: Marisa Mussi, MD, Ribeirão Preto Medical School, University of São Paulo
  • Principal Investigator: Albert Ko, MD, Yale University, Laboratory of Epidemiology and Public Health
  • Principal Investigator: Deolinda Scalabrin, Centro de Pesquisas Gonçalo Moniz, Fundação Oswaldo Cruz/MS
  • Principal Investigator: Marisa Elisabeth Lopes, Instituto Fernandes Figueira - FIOCRUZ
  • Principal Investigator: Ana Garces, MD, Fundación para la Alimentación y Nutrición de Centro América y Panamá (INCAP)
  • Principal Investigator: Jose Cordero, MD, University of Georgia
  • Principal Investigator: Carmen Milagros Velez Vega, PhD, University of Puerto Rico
  • Principal Investigator: George Seage, MD, Harvard University School of Public Health
  • Principal Investigator: Carmen Zorilla, MD, University of Puerto Rico
  • Principal Investigator: Eva Harris, PhD, University of Californina Berkeley
  • Principal Investigator: Angel Balmaseda, MINSA Central
  • Principal Investigator: Juan F Arias, MD, St. Jude Children's Research Hospital
  • Principal Investigator: Jill Lebov, PhD, RTI International
  • Principal Investigator: Teresa Ochoa Woodell, PhD, Universidad Peruana Cayetano Heredia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ACTUAL)

May 5, 2020

Study Completion (ACTUAL)

May 5, 2020

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (ESTIMATE)

August 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN ZIKA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

de-identified participant data will be entered into the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (N-DASH) system.

IPD Sharing Time Frame

IPD Sharing Time Frame: March 2022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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