Study Results
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Basic Information
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COMPLETED
6461 participants
OBSERVATIONAL
2016-06-30
2020-05-05
Brief Summary
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International Cohort Study of Children Born to Women Infected With Zika Virus During Pregnancy
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
* All infants born to women enrolled in the observational cohort are eligible for enrollment
Exclusion Criteria
* Pregnant women enrolled in other research including other ZIKV research
* Mother or custodial parent does not consent to have child participate
* Infants born to mothers that are not part of the ZIP cohort study
15 Years
FEMALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
National Institute of Environmental Health Sciences (NIEHS)
NIH
Oswaldo Cruz Foundation
OTHER
RTI International
OTHER
Responsible Party
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Principal Investigators
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Ricardo Ximenes, MD
Role: PRINCIPAL_INVESTIGATOR
Departamento de Medicina Tropical da Universidade Federal de Pernambuco-UFPE
William Britt, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama Birmingham School of Medicine
Marisa Mussi, MD
Role: PRINCIPAL_INVESTIGATOR
Ribeirão Preto Medical School, University of São Paulo
Albert Ko, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University, Laboratory of Epidemiology and Public Health
Deolinda Scalabrin
Role: PRINCIPAL_INVESTIGATOR
Centro de Pesquisas Gonçalo Moniz, Fundação Oswaldo Cruz/MS
Marisa Elisabeth Lopes
Role: PRINCIPAL_INVESTIGATOR
Instituto Fernandes Figueira - FIOCRUZ
Ana Garces, MD
Role: PRINCIPAL_INVESTIGATOR
Fundación para la Alimentación y Nutrición de Centro América y Panamá (INCAP)
Jose Cordero, MD
Role: PRINCIPAL_INVESTIGATOR
University of Georgia
Carmen Milagros Velez Vega, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Puerto Rico
George Seage, MD
Role: PRINCIPAL_INVESTIGATOR
Harvard University School of Public Health
Carmen Zorilla, MD
Role: PRINCIPAL_INVESTIGATOR
University of Puerto Rico
Eva Harris, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Californina Berkeley
Angel Balmaseda
Role: PRINCIPAL_INVESTIGATOR
MINSA Central
Juan F Arias, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Jill Lebov, PhD
Role: PRINCIPAL_INVESTIGATOR
RTI International
Teresa Ochoa Woodell, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Peruana Cayetano Heredia
Locations
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Centro de Pesquisas Gonçalo Moniz, Fundação Oswaldo Cruz/MS; Rue Waldemar Falcao
Salvador, Estado de Bahia, Brazil
Departamento de Medicina Tropical da Universidade Federal de Pernambuco-UFPE
Recife, Pernambuco, Brazil
Instituto Fernandes Figueira - FIOCRUZ
Rio de Janeiro, Rio de Janeiro, Brazil
Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes, 3900 - Monte Alegre
Ribeirão Preto, São Paulo, Brazil
Centro Medico Imbanaco
Cali, , Colombia
Fundación para la Alimentación y Nutrición de Centro América y Panamá (INCAP)
Guatemala City, , Guatemala
MINSA Central
Managua, , Nicaragua
Universidad Peruana
Lima, , Peru
University of Puerto Rico Medical Sciences Campus
San Juan, , Puerto Rico
University of Puerto Rico - Recinto de Río Piedras
San Juan, , Puerto Rico
Countries
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References
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WHO statement on the first meeting of the International Health Regulations (2005) (IHR 2005) Emergency Committee on Zika virus and observed increase in neurological disorders and neonatal malformations; 1 February 2016. Available at http://www.who.int/ mediacentre/news/statements/2016/1st-emergency-committee-zika/en/
Petersen EE, Staples JE, Meaney-Delman D, Fischer M, Ellington SR, Callaghan WM, Jamieson DJ. Interim Guidelines for Pregnant Women During a Zika Virus Outbreak--United States, 2016. MMWR Morb Mortal Wkly Rep. 2016 Jan 22;65(2):30-3. doi: 10.15585/mmwr.mm6502e1.
Powles R, Smith C, Milan S, Treleaven J, Millar J, McElwain T, Gordon-Smith E, Milliken S, Tiley C. Human recombinant GM-CSF in allogeneic bone-marrow transplantation for leukaemia: double-blind, placebo-controlled trial. Lancet. 1990 Dec 8;336(8728):1417-20. doi: 10.1016/0140-6736(90)93111-2.
CDC. Chikungunya virus. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. http://www.cdc.gov/chikungunya/hc/clinicalevaluation.html
Dengue: Guidelines for Diagnosis, Treatment, Prevention and Control: New Edition. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK143157/
CDC Zika Virus; Areas with Zika http://www.cdc.gov/zika/geo/index.html
Oliveira Melo AS, Malinger G, Ximenes R, Szejnfeld PO, Alves Sampaio S, Bispo de Filippis AM. Zika virus intrauterine infection causes fetal brain abnormality and microcephaly: tip of the iceberg? Ultrasound Obstet Gynecol. 2016 Jan;47(1):6-7. doi: 10.1002/uog.15831. No abstract available.
CDC. West Nile virus: insect repellent use & safety. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. http://www.cdc.gov/westnile/faq/repellent.html.
CDC. Zika virus. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. http://www.cdc.gov/zika/index.html
Oduyebo T, Petersen EE, Rasmussen SA, Mead PS, Meaney-Delman D, Renquist CM, Ellington SR, Fischer M, Staples JE, Powers AM, Villanueva J, Galang RR, Dieke A, Munoz JL, Honein MA, Jamieson DJ. Update: Interim Guidelines for Health Care Providers Caring for Pregnant Women and Women of Reproductive Age with Possible Zika Virus Exposure - United States, 2016. MMWR Morb Mortal Wkly Rep. 2016 Feb 12;65(5):122-7. doi: 10.15585/mmwr.mm6505e2.
Babaliche P, Doshi D. Catching Dengue Early: Clinical Features and Laboratory Markers of Dengue Virus Infection. J Assoc Physicians India. 2015 May;63(5):38-41.
Wahala WM, Silva AM. The human antibody response to dengue virus infection. Viruses. 2011 Dec;3(12):2374-95. doi: 10.3390/v3122374. Epub 2011 Nov 25.
Gibney KB, Edupuganti S, Panella AJ, Kosoy OI, Delorey MJ, Lanciotti RS, Mulligan MJ, Fischer M, Staples JE. Detection of anti-yellow fever virus immunoglobulin m antibodies at 3-4 years following yellow fever vaccination. Am J Trop Med Hyg. 2012 Dec;87(6):1112-5. doi: 10.4269/ajtmh.2012.12-0182. Epub 2012 Oct 29.
Roehrig JT, Nash D, Maldin B, Labowitz A, Martin DA, Lanciotti RS, Campbell GL. Persistence of virus-reactive serum immunoglobulin m antibody in confirmed west nile virus encephalitis cases. Emerg Infect Dis. 2003 Mar;9(3):376-9. doi: 10.3201/eid0903.020531.
http://www.salud.gov.pr/Estadisticas-Registros-y-Publicaciones/Informes %20Arbovirales/Reporte%20ArboV%20semana%204-2016.pdf
Chervenak FA, Jeanty P, Cantraine F, Chitkara U, Venus I, Berkowitz RL, Hobbins JC. The diagnosis of fetal microcephaly. Am J Obstet Gynecol. 1984 Jul 1;149(5):512-7. doi: 10.1016/0002-9378(84)90027-9.
Chervenak FA, Rosenberg J, Brightman RC, Chitkara U, Jeanty P. A prospective study of the accuracy of ultrasound in predicting fetal microcephaly. Obstet Gynecol. 1987 Jun;69(6):908-10.
Kurtz AB, Wapner RJ, Rubin CS, Cole-Beuglet C, Ross RD, Goldberg BB. Ultrasound criteria for in utero diagnosis of microcephaly. J Clin Ultrasound. 1980 Feb;8(1):11-6. doi: 10.1002/jcu.1870080104.
Hutchon DJ. Fetal ultrasound biometry: 1. Head reference values. Br J Obstet Gynaecol. 1999 Aug;106(8):875-6. doi: 10.1111/j.1471-0528.1999.tb08417.x. No abstract available.
Berger I. Prenatal microcephaly: can we be more accurate? J Child Neurol. 2009 Jan;24(1):97-100. doi: 10.1177/0883073808321045.
Julie A Boom; Microcephaly in infants and children: Etiology and evaluation UpToDate http://www.uptodate.com/contents/microcephaly-in-infants-and-children- etiology-and-evaluation?source=machineLearning&search=microcephaly+in +pregnacy&selectedTitle=2~130§ionRank=3&anchor=H55603463#H55603463 Accessed on February 16, 2016
Tolmie JL, McNay M, Stephenson JB, Doyle D, Connor JM. Microcephaly: genetic counselling and antenatal diagnosis after the birth of an affected child. Am J Med Genet. 1987 Jul;27(3):583-94. doi: 10.1002/ajmg.1320270311.
Atkinson B, Hearn P, Afrough B, Lumley S, Carter D, Aarons EJ, Simpson AJ, Brooks TJ, Hewson R. Detection of Zika Virus in Semen. Emerg Infect Dis. 2016 May;22(5):940. doi: 10.3201/eid2205.160107. No abstract available.
Medscape Medical News; FDA Issues Guidance to Protect Blood Supply From Zika Virus http://www.medscape.com/viewarticle/858976? nlid=100283_3901&src=wnl_newsalrt_160216_MSCPEDIT&uac=17333MK&impID=993653&faf=1
Sarno M, Sacramento GA, Khouri R, do Rosario MS, Costa F, Archanjo G, Santos LA, Nery N Jr, Vasilakis N, Ko AI, de Almeida AR. Zika Virus Infection and Stillbirths: A Case of Hydrops Fetalis, Hydranencephaly and Fetal Demise. PLoS Negl Trop Dis. 2016 Feb 25;10(2):e0004517. doi: 10.1371/journal.pntd.0004517. eCollection 2016 Feb.
Brasil P, Pereira JP Jr, Moreira ME, Ribeiro Nogueira RM, Damasceno L, Wakimoto M, Rabello RS, Valderramos SG, Halai UA, Salles TS, Zin AA, Horovitz D, Daltro P, Boechat M, Raja Gabaglia C, Carvalho de Sequeira P, Pilotto JH, Medialdea-Carrera R, Cotrim da Cunha D, Abreu de Carvalho LM, Pone M, Machado Siqueira A, Calvet GA, Rodrigues Baiao AE, Neves ES, Nassar de Carvalho PR, Hasue RH, Marschik PB, Einspieler C, Janzen C, Cherry JD, Bispo de Filippis AM, Nielsen-Saines K. Zika Virus Infection in Pregnant Women in Rio de Janeiro. N Engl J Med. 2016 Dec 15;375(24):2321-2334. doi: 10.1056/NEJMoa1602412. Epub 2016 Mar 4.
Lebov JF, Nason M, Stolka KB, Ximenes R, Mussi-Pinhata MM, Moye J, Zorrilla CD, Velez Vega CM, Cordero JF, Scalabrin DMF, Ko AI, Moreira MEL, Galvao LA, Britt W, Marques ETA, Balmaseda A, Harris E, Arias JF, Schultz-Cherry S, Garces AL, Krebs NF, Ochoa TJ, Ugarte-Gil CA, Fogleman E, Gabriel E, Welton M, Irizarry CM, de Moura Negrini SB, Coutinho CM, de Barros Miranda-Filho D, Montarroyos UR, Cordeiro MT, Gajewski A, Osorio JE, Figueroa L. 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. BMC Pregnancy Childbirth. 2025 Aug 30;25(1):903. doi: 10.1186/s12884-025-07774-y.
Lebov JF, Arias JF, Balmaseda A, Britt W, Cordero JF, Galvao 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 3rd, Stolka K, Ugarte-Gil CA, Vega CMV, Welton M, Ximenes R, Zorrilla C. International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol. BMC Pregnancy Childbirth. 2019 Aug 7;19(1):282. doi: 10.1186/s12884-019-2430-4.
Other Identifiers
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GN ZIKA
Identifier Type: -
Identifier Source: org_study_id
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