Zika Virus Infection's Pregnancy Consequences in French Department of America
NCT ID: NCT02916732
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
26980 participants
OBSERVATIONAL
2016-04-30
2019-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Module 1
Identification and monitoring of pregnant women who develop clinical signs of acute infection due to ZIKV (standard monitoring report)
No interventions assigned to this group
Module 2
Monitoring of pregnant women with a suspected embryofetopathy (standard monitoring report)
No interventions assigned to this group
Module 3
Trimester biological collection of all pregnant women during the outbreak of Zika (standard monitoring report)
No interventions assigned to this group
Module 4
Biological collection of maternal blood and cord blood collected during the delivery
No interventions assigned to this group
Module 5
Biological collection of maternal blood and fetal tissues of pregnant women whose pregnancies started during the outbreak of Zika , ends in an spontaneous abortion, Induced abortion or intrauterine fetal demise
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Clinical signs suggestive of ZIKV infection
* Whatever the RT-PCR analysis
* Head circumference \< 5th percentile
* Other brain morphological abnormality
* Hydramnios
* Intrauterine growth restriction (IUGR)
* Pregnant woman during epidemic period of ZIKV
* Delivery during epidemic period of ZIKV
* Spontaneous abortion or fetal death in utero during epidemic period of ZIKV
Exclusion Criteria
* No consent
M2:
* Minor
* No consent
M3:
* Minor
* Opposition
M4:
* Minor
* No consent
M5:
* Minor
* No consent
18 Years
60 Years
FEMALE
Yes
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Locations
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CH Andrée Rosemon (CHAR)
Cayenne, , French Guiana
CH de l'Ouest Guyanais Franck Joly (CHOG)
Saint-Laurent-du-Maroni, , French Guiana
CHU de Pointe à Pitre/Les Abymes
Pointe-à-Pitre, , Guadeloupe
CHU de Martinique
Fort-de-France, , Martinique
Countries
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References
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Funk AL, Hoen B, Vingdassalom I, Ryan C, Kadhel P, Schepers K, Gaete S, Tressieres B, Fontanet A. Reassessment of the risk of birth defects due to Zika virus in Guadeloupe, 2016. PLoS Negl Trop Dis. 2021 Mar 3;15(3):e0009048. doi: 10.1371/journal.pntd.0009048. eCollection 2021 Mar.
Hoen B, Schaub B, Funk AL, Ardillon V, Boullard M, Cabie A, Callier C, Carles G, Cassadou S, Cesaire R, Douine M, Herrmann-Storck C, Kadhel P, Laouenan C, Madec Y, Monthieux A, Nacher M, Najioullah F, Rousset D, Ryan C, Schepers K, Stegmann-Planchard S, Tressieres B, Volumenie JL, Yassinguezo S, Janky E, Fontanet A. Pregnancy Outcomes after ZIKV Infection in French Territories in the Americas. N Engl J Med. 2018 Mar 15;378(11):985-994. doi: 10.1056/NEJMoa1709481.
Other Identifiers
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2016-A00399-42
Identifier Type: OTHER
Identifier Source: secondary_id
C16-08
Identifier Type: -
Identifier Source: org_study_id
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