Zika in Infants and Pregnancy (ZIP)

Conditions

Zika Virus Disease (Disorder)

Keywords

Pregnancy, Infant

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.

Jill Lebov, Martha Nason, Kristen Stolka, Ricardo Arraes de Alencar Ximenes, Marisa Márcia Mussi‐Pinhata et al. (35 authors)

BMC Pregnancy and Childbirth2025-08-301 citations

10.1186/s12884-025-07774-y

International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol.

Lebov JF, Arias JF, Balmaseda A, Britt W, Cordero JF, Galvão LA, Garces AL, Hambidge KM, Harris E, Ko A, Krebs N, Marques ETA, Martinez AM, McClure E, Miranda-Filho DB, Moreira MEL, Mussi-Pinhata MM, Ochoa TJ, Osorio JE, Scalabrin DMF, Schultz-Cherry S, Seage GR, Stolka K, Ugarte-Gil CA, Vega CMV, Welton M, Ximenes R, Zorrilla C.

2019-08-0722 citations

10.1186/s12884-019-2430-4

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

15 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of congenital malformations for ZIKV infected participants	Time of birth of infant	To measure the incidence of congenital malformations in fetuses/infants.
Incidence of adverse fetal outcomes for ZIKV infected participants	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.
Incidence of congenital malformations for ZIKV symptomatic participants	Time of birth of infant	To measure the incidence of congenital malformations in fetuses/infants.
Incidence of adverse fetal outcomes for ZIKV symptomatic participants	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.

Countries

Brazil, Colombia, Guatemala, Nicaragua, Peru, Puerto Rico

Outcome results