International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol
Abstract Background Until recently, Zika virus (ZIKV) infections were considered mild and self-limiting. Since 2015, they have been associated with an increase in microcephaly and other birth defects in newborns. While this association has been observed in case reports and epidemiological studies, t...
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| Format: | Article |
| Language: | English |
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BMC
2019-08-01
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| Series: | BMC Pregnancy and Childbirth |
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| Online Access: | http://link.springer.com/article/10.1186/s12884-019-2430-4 |
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| author | Jill F. Lebov Juan F. Arias Angel Balmaseda William Britt José F. Cordero Luiz Augusto Galvão Ana Lucía Garces K. Michael Hambidge Eva Harris Albert Ko Nancy Krebs Ernesto T. A. Marques Alexander M. Martinez Elizabeth McClure Democrito B. Miranda-Filho Maria Elisabeth Lopes Moreira Marisa M. Mussi-Pinhata Theresa J. Ochoa Jorge E. Osorio Deolinda M. F. Scalabrin Stacey Schultz-Cherry George R. Seage Kristen Stolka César Augusto Ugarte-Gil Carmen Milagros Velez Vega Michael Welton Ricardo Ximenes Carmen Zorrilla |
| author_facet | Jill F. Lebov Juan F. Arias Angel Balmaseda William Britt José F. Cordero Luiz Augusto Galvão Ana Lucía Garces K. Michael Hambidge Eva Harris Albert Ko Nancy Krebs Ernesto T. A. Marques Alexander M. Martinez Elizabeth McClure Democrito B. Miranda-Filho Maria Elisabeth Lopes Moreira Marisa M. Mussi-Pinhata Theresa J. Ochoa Jorge E. Osorio Deolinda M. F. Scalabrin Stacey Schultz-Cherry George R. Seage Kristen Stolka César Augusto Ugarte-Gil Carmen Milagros Velez Vega Michael Welton Ricardo Ximenes Carmen Zorrilla |
| author_sort | Jill F. Lebov |
| collection | DOAJ |
| description | Abstract Background Until recently, Zika virus (ZIKV) infections were considered mild and self-limiting. Since 2015, they have been associated with an increase in microcephaly and other birth defects in newborns. While this association has been observed in case reports and epidemiological studies, the nature and extent of the relationship between ZIKV and adverse pregnancy and pediatric health outcomes is not well understood. With the unique opportunity to prospectively explore the full spectrum of issues related to ZIKV exposure during pregnancy, we undertook a multi-country, prospective cohort study to evaluate the association between ZIKV and pregnancy, neonatal, and infant outcomes. Methods At research sites in ZIKV endemic regions of Brazil (4 sites), Colombia, Guatemala, Nicaragua, Puerto Rico (2 sites), and Peru, up to 10,000 pregnant women will be recruited and consented in the first and early second trimesters of pregnancy and then followed through delivery up to 6 weeks post-partum; their infants will be followed until at least 1 year of age. Pregnant women with symptomatic ZIKV infection confirmed by presence of ZIKV RNA and/or IgM for ZIKV will also be enrolled, regardless of gestational age. Participants will be tested monthly for ZIKV infection; additional demographic, physical, laboratory and environmental data will be collected to assess the potential interaction of these variables with ZIKV infection. Delivery outcomes and detailed infant assessments, including physical and neurological outcomes, will be obtained. Discussion With the emergence of ZIKV in the Americas and its association with adverse pregnancy outcomes in this region, a much better understanding of the spectrum of clinical outcomes associated with exposure to ZIKV during pregnancy is needed. This cohort study will provide information about maternal, fetal, and infant outcomes related to ZIKV infection, including congenital ZIKV syndrome, and manifestations that are not detectable at birth but may appear during the first year of life. In addition, the flexibility of the study design has provided an opportunity to modify study parameters in real time to provide rigorous research data to answer the most critical questions about the impact of congenital ZIKV exposure. Trial registration NCT02856984. Registered August 5, 2016. Retrospectively registered. |
| first_indexed | 2024-12-19T07:04:17Z |
| format | Article |
| id | doaj.art-ffcfd155e7db4c859a49521fc6f6d180 |
| institution | Directory Open Access Journal |
| issn | 1471-2393 |
| language | English |
| last_indexed | 2024-12-19T07:04:17Z |
| publishDate | 2019-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pregnancy and Childbirth |
| spelling | doaj.art-ffcfd155e7db4c859a49521fc6f6d1802022-12-21T20:31:19ZengBMCBMC Pregnancy and Childbirth1471-23932019-08-0119111010.1186/s12884-019-2430-4International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocolJill F. Lebov0Juan F. Arias1Angel Balmaseda2William Britt3José F. Cordero4Luiz Augusto Galvão5Ana Lucía Garces6K. Michael Hambidge7Eva Harris8Albert Ko9Nancy Krebs10Ernesto T. A. Marques11Alexander M. Martinez12Elizabeth McClure13Democrito B. Miranda-Filho14Maria Elisabeth Lopes Moreira15Marisa M. Mussi-Pinhata16Theresa J. Ochoa17Jorge E. Osorio18Deolinda M. F. Scalabrin19Stacey Schultz-Cherry20George R. Seage21Kristen Stolka22César Augusto Ugarte-Gil23Carmen Milagros Velez Vega24Michael Welton25Ricardo Ximenes26Carmen Zorrilla27Social, Statistical and Environmental Sciences, RTI InternationalDepartment of Infectious Diseases, St Jude Children’s Research HospitalCentro Nacional de Diagnostico y Referencia, Complejo Nacional de SaludDepartment of Pediatrics, University of Alabama at BirminghamDepartment of Epidemiology and Biostatistics, College of Public Health, University of GeorgiaCenter for Global Health – CRIS, FIOCRUZFundación para la Alimentación y Nutrición de Centro América y Panamá (INCAP)Section of Nutrition, Pediatrics, University of ColoradoDivision of Infectious Diseases and Vaccinology, School of Public Health, University of CaliforniaDepartment of Epidemiology of Microbial Diseases, Yale School of Public HealthSection of Nutrition, Pediatrics, University of ColoradoSchool of Public Health, University of PittsburghDirector of Research Institute at Imbanaco Medical CenterSocial, Statistical and Environmental Sciences, RTI InternationalPrograma de Pós-Graduação em Ciências da Saúde (PPGCS) da Universidade de Pernambuco, Microcephaly Epidemic Research GroupInstituto Fernandes Figueira – FIOCRUZRibeirão Preto Medical SchoolInstituto de Medicina Tropical Alexander von Humboldt and Facultad de Medicina, Universidad Peruana Cayetano HerediaDepartment of Pathobiological Sciences, University of WisconsinDepartment of Epidemiology of Microbial Diseases, Yale School of Public HealthDepartment of Infectious Diseases, St Jude Children’s Research HospitalDepartment of Epidemiology, Harvard Chan School of Public HealthSocial, Statistical and Environmental Sciences, RTI InternationalInstituto de Medicina Tropical Alexander von Humboldt and Facultad de Medicina, Universidad Peruana Cayetano HerediaUniversity of Puerto RicoDepartment of Epidemiology and Biostatistics, College of Public Health, University of GeorgiaDepartamento de Medicina Tropical da Universidade Federal de Pernambuco, Microcephaly Epidemic Research GroupMaternal-Infant Studies Center (CEMI)Abstract Background Until recently, Zika virus (ZIKV) infections were considered mild and self-limiting. Since 2015, they have been associated with an increase in microcephaly and other birth defects in newborns. While this association has been observed in case reports and epidemiological studies, the nature and extent of the relationship between ZIKV and adverse pregnancy and pediatric health outcomes is not well understood. With the unique opportunity to prospectively explore the full spectrum of issues related to ZIKV exposure during pregnancy, we undertook a multi-country, prospective cohort study to evaluate the association between ZIKV and pregnancy, neonatal, and infant outcomes. Methods At research sites in ZIKV endemic regions of Brazil (4 sites), Colombia, Guatemala, Nicaragua, Puerto Rico (2 sites), and Peru, up to 10,000 pregnant women will be recruited and consented in the first and early second trimesters of pregnancy and then followed through delivery up to 6 weeks post-partum; their infants will be followed until at least 1 year of age. Pregnant women with symptomatic ZIKV infection confirmed by presence of ZIKV RNA and/or IgM for ZIKV will also be enrolled, regardless of gestational age. Participants will be tested monthly for ZIKV infection; additional demographic, physical, laboratory and environmental data will be collected to assess the potential interaction of these variables with ZIKV infection. Delivery outcomes and detailed infant assessments, including physical and neurological outcomes, will be obtained. Discussion With the emergence of ZIKV in the Americas and its association with adverse pregnancy outcomes in this region, a much better understanding of the spectrum of clinical outcomes associated with exposure to ZIKV during pregnancy is needed. This cohort study will provide information about maternal, fetal, and infant outcomes related to ZIKV infection, including congenital ZIKV syndrome, and manifestations that are not detectable at birth but may appear during the first year of life. In addition, the flexibility of the study design has provided an opportunity to modify study parameters in real time to provide rigorous research data to answer the most critical questions about the impact of congenital ZIKV exposure. Trial registration NCT02856984. Registered August 5, 2016. Retrospectively registered.http://link.springer.com/article/10.1186/s12884-019-2430-4Zika virusPregnancyLatin AmericaMicrocephaly |
| spellingShingle | Jill F. Lebov Juan F. Arias Angel Balmaseda William Britt José F. Cordero Luiz Augusto Galvão Ana Lucía Garces K. Michael Hambidge Eva Harris Albert Ko Nancy Krebs Ernesto T. A. Marques Alexander M. Martinez Elizabeth McClure Democrito B. Miranda-Filho Maria Elisabeth Lopes Moreira Marisa M. Mussi-Pinhata Theresa J. Ochoa Jorge E. Osorio Deolinda M. F. Scalabrin Stacey Schultz-Cherry George R. Seage Kristen Stolka César Augusto Ugarte-Gil Carmen Milagros Velez Vega Michael Welton Ricardo Ximenes Carmen Zorrilla International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol BMC Pregnancy and Childbirth Zika virus Pregnancy Latin America Microcephaly |
| title | International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol |
| title_full | International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol |
| title_fullStr | International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol |
| title_full_unstemmed | International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol |
| title_short | International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol |
| title_sort | international prospective observational cohort study of zika in infants and pregnancy zip study study protocol |
| topic | Zika virus Pregnancy Latin America Microcephaly |
| url | http://link.springer.com/article/10.1186/s12884-019-2430-4 |
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