Evidence map›Paper›PMID 40885911›Full record

Observational studyBMC pregnancy and childbirth2025

Zika in Infants and Pregnancy (ZIP) study: results from a prospective international cohort study of prenatal Zika virus infection and adverse fetal and infant outcomes.

Jill Farnell Lebov, Martha Nason, Kristen B Stolka, Ricardo Ximenes, Marisa M Mussi-Pinhata, Jack Moye, Carmen D Zorrilla, Carmen M Velez Vega, José F Cordero, Deolinda M F Scalabrin and 25 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BMC pregnancy and childbirth, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02856984 (International Prospective Observational Cohort Study of Zika in Infants), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02856984 completednot on this map

International Prospective Observational Cohort Study of Zika in Infants

TypeobservationalSponsorRTI InternationalRan2016 to 2020Enrolled6,461ConditionsZika Virus Disease (Disorder)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

35 authors.

Jill Farnell LebovSocial, Statistical and Environmental Health Sciences RTI International, Durham, NC, England. jlebov@rti.org.
Martha NasonCenter for Vaccine Innovation and Access, PATH, Washington, DC, USA.
Kristen B StolkaSocial, Statistical and Environmental Health Sciences RTI International, Durham, NC, England.
Ricardo XimenesDepartamento de Medicina Tropical da, Universidade Federal de Pernambuco, Microcephaly Epidemic Research Group Recife, Recife, Brazil.
Marisa M Mussi-PinhataRibeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.
Jack MoyeEunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health, DHHS, Bldg. 6710B Rm. 2130MSC 7002 9000 Rockville Pike Bethesda, Bethesda, 20892-7002, MD, USA.
Carmen D ZorrillaMaternal-Infant Studies Center (CEMI) UPR School of Medicine, San Juan, Puerto Rico.
Carmen M Velez VegaUniversity of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico.
José F CorderoDepartment of Epidemiology and Biostatistics College of Public Health, University of Georgia, Athens, GA, USA.
Deolinda M F ScalabrinDepartment of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, USA.
Albert I KoDepartment of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, USA.
Maria Elisabeth Lopes MoreiraInstituto Fernandes Figueira-Fiocruz, Rio de Janeiro, Brazil.
Luiz Augusto GalvãoGlobal Health Center-CRIS Fiocruz , Rio de Janeiro, Brazil.
William BrittDepartment of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA.
Ernesto T A MarquesSchool of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.
Angel BalmasedaLaboratorio Nacional de Virología Centro Nacional de Diagnóstico y Referencia Ministerio de Salud, Managua, Nicaragua.
Eva HarrisDivision of Infectious Diseases and Vaccinology, School of Public Health, University of California, Berkeley, CA, USA.
Juan F AriasDepartment of Infectious Diseases, St Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, TN, 38105, USA.
Stacey Schultz-CherryDepartment of Host-Microbe Interactions, St Jude Children's Research Hospital, Memphis, TN, USA.
Ana Lucía GarcesFundación Para La Alimentación y Nutrición de Centro América y Panamá (INCAP), Guatemala City, Guatemala.
Nancy F KrebsSection of Nutrition, Department of Pediatrics, University of Colorado School of Medicine, Denver, CO, USA.
Theresa J OchoaInstituto de Medicina Tropical Alexander Von Humboldt and Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru.
César Augusto Ugarte-GilInstituto de Medicina Tropical Alexander Von Humboldt and Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru.
Elizabeth FoglemanSocial, Statistical and Environmental Health Sciences RTI International, Durham, NC, England.
Erin GabrielSection of Biostatistics Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Michael WeltonDepartment of Epidemiology and Biostatistics College of Public Health, University of Georgia, Athens, GA, USA.
Carmen M IrizarryPuerto Rico-AIDS CRS Medical Science Campus, Pathology San Juan, San Juan, Puerto Rico.
Silvia Biason de Moura NegriniRibeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.
Conrado Milani CoutinhoRibeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.
Demócrito de Barros Miranda-FilhoPrograma de Pós-Graduação em Ciências da Saúde (PPGCS) da, Universidade de Pernambuco, Microcephaly Epidemic Research Group, Recife, Brazil.
Ulisses Ramos MontarroyosPrograma de Pós-Graduação em Ciências da Saúde (PPGCS) da, Universidade de Pernambuco, Microcephaly Epidemic Research Group, Recife, Brazil.
Marli Tenorio CordeiroDepartment of Virology and Experimental Therapeutics, Instituto Aggeu Magalhães, Fiocruz-Pernambuco, Recife, Brazil.
Anna GajewskiSustainable Sciences Institute Managua, Managua, Nicaragua.
Jorge E OsorioDepartment of Pathobiological Sciences, University of Wisconsin, Madison, WI, USA.
Lester FigueroaFundación Para La Alimentación y Nutrición de Centro América y Panamá (INCAP), Guatemala City, Guatemala.

Funding

PHACS - Data and Operations CenterU01HD052102 · NICHD · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI WILLIAMS, PAIGE L · 2005 to 2019
$242.7M
Zika in Pregnancy Supplemental Funding requestU01HD040636 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI MCCLURE, ELIZABETH M · 2001 to 2017
$37.5M
T Cell Responses Following DENV Natural Infections and Live-Attenuated Dengue Virus VaccinationP01AI106695 · NIAID · UNIVERSITY OF CALIFORNIA BERKELEY · PI Aravinda M. DeSilva · 2015 to 2026
$34.1M
The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)UM1AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI BEATRIZ GRINSZTEJN · 2012 to 2026
$26.3M
Systems Biology Identifies Restriction Factors for West Nile VirusU19AI106772 · NIAID · UNIVERSITY OF WISCONSIN-MADISON · PI WATERS, KATRINA M. · 2013 to 2017
$26.1M
Naturally-Acquired and Vaccine-Mediated Immunity to LeptospirosisR01AI121207 · NIAID · YALE UNIVERSITY · PI KO, ALBERT ICKSANG, REIS, MITERMAYER GALVAO DOS · 2016 to 2020
$6.4M
CMV Vaccines: Reinfection and Antigenic Variation (Vision and auditory screening in infants born to women enrolled in ZIP)R01HD061959 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI BRITT, WILLIAM JARVIS, MUSSI-PINHATA, MARISA MARCIA · 2011 to 2023
$5.9M
The Global Network and Preconception Maternal NutritionU10HD076474 · NICHD · UNIVERSITY OF COLORADO DENVER · PI HAMBIDGE, K MICHAEL, KREBS, NANCY F · 2013 to 2017
$5.1M
Eunice Kennedy Shriver National Institute of Child Health and Human Development Contracts No. HHSN275201800001I /HHSN27500003, HHSN201800001I/HHSN27500006 and HHSN201800001I/75N94020F00003National Institute of Allergy and Infectious Diseases R01HD061959, R01HD061959, R01AI121207, UM1AI069476, U10HD076474, U01HD052102, P01AI106695, U19AI106772, U01HD040636, HHSN272201400006C and HHSN272201600013CNIAID NIH HHS HHSN272201400006CNIAID NIH HHS HHSN272201600013CNIAID NIH HHS P01 AI106695NIAID NIH HHS R01 AI121207NIAID NIH HHS U19 AI106772NIAID NIH HHS UM1 AI069476NICHD NIH HHS HHSN275201800001CNICHD NIH HHS HHSN275201800001INICHD NIH HHS R01 HD061959NICHD NIH HHS U01 HD040636NICHD NIH HHS U01 HD052102NICHD NIH HHS U10 HD076474
6 · The paper itself

Abstract

backgroundBefore Zika virus (ZIKV) infections were observed in the Americas, an association between ZIKV and microcephaly or other congenital malformations was not well documented. Initial reports suggested strong associations between ZIKV and congenital malformations, but plausible estimates of causal effects from prospective studies with adequate sample size and covariate data were few.

methodsFrom 2016-2018, the Zika in Infants and Pregnancy (ZIP) study enrolled pregnant people before 18 weeks gestation or with confirmed symptomatic ZIKV in a prospective cohort across 10 sites in South and Central America, and in Puerto Rico. Pregnancies were followed monthly through delivery and 6 weeks postpartum. Infants were followed quarterly to age 12 months. Prespecified co-primary analyses evaluated the associations between a composite endpoint of adverse fetal, neonatal, and infant outcomes with intrauterine ZIKV exposure overall and with symptomatic intrauterine ZIKV exposure. Secondary analyses separately evaluated the association of intrauterine ZIKV exposure with individual components of the primary endpoint.

resultsSix thousand one hundred pregnant participants were included in the primary analysis, including 61 with ZIKV infection during pregnancy confirmed by a ZIKV-specific RNA test. For the primary analyses, the relative risk (RR) for the composite endpoint associated with any ZIKV exposure was 1.64 (95% CI: 0.65, 4.13) and with symptomatic ZIKV exposure 1.08 (95% CI: 0.15, 7.64). Sensitivity analyses provided similar results. Secondary analyses showed significant adjusted RRs [95% CI] for stillbirth (4.28 [1.39, 13.21]), infant death within six weeks (6.20 [1.08, 35.60], and fetal loss before 20 weeks (3.72 [1.82, 7.59]).

conclusionsThe ZIP study identified an elevated but not statistically significant risk of the primary composite outcome with intrauterine ZIKV exposure, and a significantly increased risk of some adverse fetal and infant outcomes with intrauterine ZIKV exposure in secondary analyses. Fewer than expected infections observed during pregnancy, coincident with a waning epidemic, limited study power to evaluate risk. Combining data from multiple cohorts for future meta-analysis may better define the risks of intrauterine ZIKV exposure.

trial registrationNCT02856984. Registered August 5, 2016. Retrospectively registered.

Indexed as

MicrocephalyPregnancy Complications, InfectiousZika Virus InfectionAdultCentral AmericaFemaleHumansInfantInfant, NewbornMalePregnancyPregnancy OutcomeProspective StudiesPuerto RicoSouth AmericaYoung AdultFetalLatin AmericaMicrocephalyNeonatal outcomesPregnancyZika virus

Identifiers

PMID40885911
PMCPMC12399002

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.