title: Zika virus infection in pregnant women in Honduras: study protocol.
abstract: BACKGROUND
  Although there is increasing evidence for a relationship between symptomatic Zika virus (ZIKV) maternal infection, and microcephaly, a firm causal relation has yet to be established by epidemiologic studies. Studies also need to be conducted in recently infected settings. Our objectives are to assess the frequency of ZIKV infection during pregnancy in Honduras and the association of microcephaly with ZIKV infection.
  
  
  METHODS
  We will perform a prospective study enrolling pregnant women at their first antenatal visit and following them up until delivery. At the time of enrollment, women will be interviewed to collect socio-demographic data, data needed to locate them for potential additional follow-up, and data about ZIKV symptoms during pregnancy. We will also collect maternal blood as soon as possible after enrollment. A probable maternal ZIKV infection will be defined as positive for maternal ZIKV IgM. A confirmed maternal ZIKV infection will be defined as positive for ZIKV IgM confirmed by plaque reduction neutralization test. Microcephaly at birth will be defined as an occipito-frontal circumference <2SD for sex and gestational age. Our objective is to enroll 2000 pregnant women. In a first step, we will follow a case cohort design and only analyze blood samples for cases and a sub-cohort of 200 women randomly selected. Blood samples for the entire population will be analyzed at a later stage if funds are available.
  
  
  CONCLUSIONS
  This protocol was designed to be implemented with minimal resources. It allows a cohort to be built, which could be a foundation for future in-depth and follow-up studies.
authors.affiliation: School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Ste. 2430, New Orleans, LA, 70112, USA. pbuekens@tulane.edu.
authors.forename: Pierre
authors.identifier: http://orcid.org/0000-0002-4294-8559
authors.initials: P
authors.lastname: Buekens
authors.affiliation: Instituto de Enfermedades Infecciosas y Parasitología Antonio Vidal; Hospital Escuela Universitario, Facultad de Ciencias Médicas, UNAH, Calle La Salud, Boulevard a Suyapa, Colonia Quezada, Tegucigalpa, Honduras.
authors.forename: Jackeline
authors.initials: J
authors.lastname: Alger
authors.affiliation: Instituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024, C1414CPV, Buenos Aires, Argentina.
authors.forename: Fernando
authors.initials: F
authors.lastname: Althabe
authors.affiliation: Instituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024, C1414CPV, Buenos Aires, Argentina.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Bergel
authors.affiliation: Instituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024, C1414CPV, Buenos Aires, Argentina.
authors.forename: Amanda M
authors.initials: AM
authors.lastname: Berrueta
authors.affiliation: Departamento de Ginecología y Obstetricia, Hospital Escuela, Calle La Salud, Boulevard a Suyapa, Colonia Quezada, Tegucigalpa, Honduras.
authors.forename: Carolina
authors.initials: C
authors.lastname: Bustillo
authors.affiliation: Unidad de Investigación Clínica y Epidemiológica Montevideo (UNICEM), Hospital de Clinicas, Avenida Italia s/n - piso 4°, Montevideo, 11600, Uruguay.
authors.forename: Maria-Luisa
authors.initials: ML
authors.lastname: Cafferata
authors.affiliation: Department of Epidemiology, Tulane School of Public Health and Tropical Medicine, Tulane University, Ste. 2012, 1440 Canal St., New Orleans, LA, 70112, USA.
authors.forename: Emily
authors.initials: E
authors.lastname: Harville
authors.affiliation: Región Sanitaria Metropolitana Distrito Central de Francisco Morazán, Tegucigalpa, Honduras.
authors.forename: Karla
authors.initials: K
authors.lastname: Rosales
authors.affiliation: School of Public Health and Tropical Medicine, Tulane University, 1324 Tulane Avenue, JBJ Building, Room 509, New Orleans, LA, 70112, USA.
authors.forename: Dawn M
authors.initials: DM
authors.lastname: Wesson
authors.affiliation: Instituto de Enfermedades Infecciosas y Parasitología Antonio Vidal; Hospital Escuela Universitario, Calle La Salud, Boulevard a Suyapa, Colonia Quezada, Tegucigalpa, Honduras.
authors.forename: Concepcion
authors.initials: C
authors.lastname: Zuniga
mesh_terms: D015331:Cohort Studies; D015340:Epidemiologic Research Design; D005260:Female; D006801:Humans; D008831:Microcephaly / Q000453:epidemiology / Q000209:etiology*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000821:virology*; D011256:Pregnancy Outcome; D000071243:Zika Virus Infection / Q000150:complications* / Q000453:epidemiology
keywords: Honduras; Microcephaly; Pregnancy; Zika virus