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| Name | Class |
|---|---|
| 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) |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of congenital malformations for ZIKV infected participants | To measure the incidence of congenital malformations in fetuses/infants. | Time of birth of infant |
| Incidence of congenital malformations for ZIKV infected participants | To measure the incidence of congenital malformations in fetuses/infants. | 3 months of age |
| Incidence of congenital malformations for ZIKV infected participants | To measure the incidence of congenital malformations in fetuses/infants. | 6 months of age |
| Incidence of congenital malformations for ZIKV infected participants | To measure the incidence of congenital malformations in fetuses/infants. | 12 months of age |
| Incidence of adverse fetal outcomes for ZIKV infected participants | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria: Pregnant Women
Inclusion Criteria (newborn)
Exclusion Criteria (newborn)
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Pesquisas Gonçalo Moniz, Fundação Oswaldo Cruz/MS; Rue Waldemar Falcao | Salvador | Estado de Bahia | 40296-710 | Brazil | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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/ | ||
| 26796813 | Background | 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. | |
| 1978880 |
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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.
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IPD Sharing Time Frame: March 2022
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| ID | Term |
|---|---|
| D000071243 | Zika Virus Infection |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| Oswaldo Cruz Foundation | OTHER |
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maternal samples from urine, blood, genital secretions, saliva, and breast milk, and when available amniotic fluid and tissue; infant urine, blood, and saliva
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 | 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 | To measure the incidence of congenital malformations in fetuses/infants. | Time of birth of infant |
| Incidence of congenital malformations for ZIKV symptomatic participants | To measure the incidence of congenital malformations in fetuses/infants. | 3 months of age |
| Incidence of congenital malformations for ZIKV symptomatic participants | To measure the incidence of congenital malformations in fetuses/infants. | 6 months of age |
| Incidence of congenital malformations for ZIKV symptomatic participants | To measure the incidence of congenital malformations in fetuses/infants. | 12 months of age |
| Incidence of adverse fetal outcomes for ZIKV symptomatic participants | 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 | 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 | 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 | 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 |
| 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 | Principal Investigator |
| Departamento de Medicina Tropical da Universidade Federal de Pernambuco-UFPE |
| Recife |
| Pernambuco |
| CEP: 50670-901 |
| Brazil |
| Instituto Fernandes Figueira - FIOCRUZ | Rio de Janeiro | Rio de Janeiro | 22250-020 | Brazil |
| Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes, 3900 - Monte Alegre | Ribeirão Preto | São Paulo | 14049-900 | Brazil |
| Centro Medico Imbanaco | Cali | Colombia |
| Fundación para la Alimentación y Nutrición de Centro América y Panamá (INCAP) | Guatemala City | Guatemala |
| MINSA Central | Managua | 16064 | Nicaragua |
| Universidad Peruana | Lima | Peru |
| University of Puerto Rico Medical Sciences Campus | San Juan | 00921 | Puerto Rico |
| University of Puerto Rico - Recinto de Río Piedras | San Juan | 00936 | Puerto Rico |
| Background |
| 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. |
| Background | CDC. Chikungunya virus. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. http://www.cdc.gov/chikungunya/hc/clinicalevaluation.html |
| 23762963 | Background | 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/ |
| Background | CDC Zika Virus; Areas with Zika http://www.cdc.gov/zika/geo/index.html |
| 26731034 | Background | 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. |
| Background | 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. |
| Background | CDC. Zika virus. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. http://www.cdc.gov/zika/index.html |
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| 22355444 | Background | 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. |
| 23109371 | Background | 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. |
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| 3554067 | Background | 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. |
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| 10453845 | Background | 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. |
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| Background | 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 |
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| 27088817 | Background | 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. |
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| 26943629 | Background | 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. |
| 40885911 | Derived | 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. |
| 31391005 | Derived | 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. |
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |