International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol.
Adolescent
Adult
Antibodies, Viral
/ blood
Brazil
/ epidemiology
Cohort Studies
Colombia
/ epidemiology
Congenital Abnormalities
/ epidemiology
Female
Fetal Growth Retardation
/ epidemiology
Guatemala
/ epidemiology
Humans
Immunoglobulin M
Infant
Infant, Newborn
Male
Nicaragua
/ epidemiology
Peru
/ epidemiology
Pre-Eclampsia
/ epidemiology
Pregnancy
Pregnancy Complications
/ epidemiology
Pregnancy Complications, Infectious
/ epidemiology
Pregnancy Outcome
/ epidemiology
Pregnancy Trimester, First
Pregnancy Trimester, Second
Premature Birth
/ epidemiology
Prospective Studies
Puerto Rico
/ epidemiology
RNA, Viral
/ blood
Young Adult
Zika Virus
Zika Virus Infection
/ epidemiology
Latin America
Microcephaly
Pregnancy
Zika virus
Journal
BMC pregnancy and childbirth
ISSN: 1471-2393
Titre abrégé: BMC Pregnancy Childbirth
Pays: England
ID NLM: 100967799
Informations de publication
Date de publication:
07 Aug 2019
07 Aug 2019
Historique:
received:
14
03
2019
accepted:
26
07
2019
entrez:
9
8
2019
pubmed:
9
8
2019
medline:
31
1
2020
Statut:
epublish
Résumé
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. 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. 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. NCT02856984 . Registered August 5, 2016. Retrospectively registered.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
NCT02856984 . Registered August 5, 2016. Retrospectively registered.
Identifiants
pubmed: 31391005
doi: 10.1186/s12884-019-2430-4
pii: 10.1186/s12884-019-2430-4
pmc: PMC6686399
doi:
Substances chimiques
Antibodies, Viral
0
Immunoglobulin M
0
RNA, Viral
0
Banques de données
ClinicalTrials.gov
['NCT02856984']
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
282Subventions
Organisme : National Institute of Child Health and Human Development
ID : 3U01HD040636-16S1
Commentaires et corrections
Type : ErratumIn
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