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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00399-42 | Other Identifier | France ANSM |
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The Zika (ZIKV) epidemic has spread into the three French Overseas Departments in the Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for the evaluation of potential complications due to having ZIKV infection during pregnancy. This study is meant to collect, within usual care practices, clinical and paraclinical information which will allow the precise description of the consequences of ZIKV infection occurring during pregnancy.
This is a prospective observational, non-interventional study that has been integrated into the usual standard of care practices. All information and biological samples collected during the course of this project will be done through the new medical standard of care which has been put in place during the ZIKV epidemic in the DFAs; this new standard of care is a result of existing recommendations from medical professionals and/or public health authorities. Outside of these recommendations, no invasive procedure will be done simply to satisfy an objective of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Module 1 | Identification and monitoring of pregnant women who develop clinical signs of acute infection due to ZIKV (standard monitoring report) | ||
| Module 2 | Monitoring of pregnant women with a suspected embryofetopathy (standard monitoring report) | ||
| Module 3 | Trimester biological collection of all pregnant women during the outbreak of Zika (standard monitoring report) | ||
| Module 4 | Biological collection of maternal blood and cord blood collected during the delivery | ||
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ZIKV infection during pregnancy | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of microcephaly and other fetal abnormalities | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of risk factor for the occurence of congenital abnormalities | 12 month |
M1:
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M2:
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M3:
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M4:
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M5:
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The population of this study is women who have been pregnant during the 2016 ZIKV Epidemic in the DFAs. Five study arms (hereafter called 'modules') have been defined with various inclusion criteria for each module.
M1: Pregnant women with clinical signs of acute ZIKV infection
Module 2: Pregnant women for which an abnormality has been detected in the fetus.
Module 3: Bio-bank of serum, collected once per trimester, from all pregnant women.
Module 4: Bio-bank of maternal blood and infant cord blood, taken the day of birth in all mothers and their babies in the 3 DFAs.
Module 5: Bio-bank of maternal blood and fetal tissues from women in whom the pregnancy was terminated due to miscarriage, abortion on medical grounds, or a fetal death in-utero.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Andrée Rosemon (CHAR) | Cayenne | French Guiana | ||||
| CH de l'Ouest Guyanais Franck Joly (CHOG) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33657112 | Result | 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. | |
| 29539287 | Result | 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. |
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| ID | Term |
|---|---|
| D008831 | Microcephaly |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D065703 | Malformations of Cortical Development, Group I |
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| Saint-Laurent-du-Maroni |
| French Guiana |
| CHU de Pointe à Pitre/Les Abymes | Pointe-à-Pitre | Guadeloupe |
| CHU de Martinique | Fort-de-France | Martinique |
| D054220 | Malformations of Cortical Development |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |