Zika in Infants and Pregnancy (ZIP)

Completed

• Conditions: Zika Virus Disease (Disorder)

• Registration Number: NCT02856984
• Lead Sponsor: RTI International

Brief 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.

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-05
• Primary Completion: 2020-05-05
• Study Completion: 2020-05-05
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-12
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6461

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of congenital malformations for ZIKV infected participants	12 months of age	To measure the incidence of congenital malformations in fetuses/infants.
Incidence of adverse fetal outcomes for ZIKV infected participants	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.
Incidence of congenital malformations for ZIKV symptomatic participants	12 months of age	To measure the incidence of congenital malformations in fetuses/infants.
Incidence of adverse fetal outcomes for ZIKV symptomatic participants	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.

Trial Locations

Locations (10)

Departamento de Medicina Tropical da Universidade Federal de Pernambuco-UFPE; 🇧🇷 Recife, PE, Brazil

Instituto Fernandes Figueira - FIOCRUZ; 🇧🇷 Rio de Janeiro, RJ, Brazil

Fundación para la Alimentación y Nutrición de Centro América y Panamá (INCAP); 🇬🇹 Guatemala, Guatemala

Universidad Peruana; 🇵🇪 Lima, Peru

Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes, 3900 - Monte Alegre; 🇧🇷 Ribeirão Preto, SP, Brazil

University of Puerto Rico Medical Sciences Campus; 🇵🇷 San Juan, Puerto Rico

University of Puerto Rico - Recinto de Río Piedras; 🇵🇷 San Juan, Puerto Rico

Centro de Pesquisas Gonçalo Moniz, Fundação Oswaldo Cruz/MS; Rue Waldemar Falcao; 🇧🇷 Salvador, Bahia, Brazil

Centro Medico Imbanaco; 🇨🇴 Cali, Colombia

MINSA Central; 🇳🇮 Managua, Nicaragua