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The Zika 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 (including imaging and laboratory results) as well as biological samples allowing the precise description of the consequences of ZIKV infection during pregnancy.
This study is the 2nd arm of a global research program in the 3 French Overseas Departments in the Caribbean. It is complementary to the first arm (ZIKA-DFA-FE) consisting in the follow-up of women in the French Overseas Departments who are pregnant during the Zika epidemic period.
The study population is made up of infants born during and up to 9 months after the end of the Zika epidemic period in the French Overseas Departments.
The data and biological specimens collected for this project will be done so through the recommended standard of care which has been put in place considering the ZIKV epidemic in the 3 French Overseas Departments, upholding existing recommendations (profession and/or recommendation from the public health authorities)
At birth (from Day 0 to Day 4):
Follow-up from Day 4 to 2 years:
- Clinical examination focusing on neuropsychomotor development at the 2nd, 4th, 9th, 18th and 24th month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Monitoring of children born without congenital anomalies to mothers with biologically confirmed ZIKV's infection during the pregnancy | ||
| Cohort 2 | Monitoring of children born with congenital anomalies to mothers with biologically confirmed ZIKV's infection during the pregnancy | ||
| Cohort 3 | Monitoring of children born without congenital anomalies to mothers with no biologically confirmed ZIKV's infection during the pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fundus examination | Other | In cohort 3, a fundus examination will be carried in addition to the current medical practice. This exam is part of current medical practice for other groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Embryofoetopathy incidence within cohort 1 and 3 | incidence comparison between the 2 groups and the calcul of adjusted incidence ratios | 24 months |
| Comparison of congenital abnormality incidence rates between cohorts 1 and 3 |
| 24 months |
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Cohort 1:
Inclusion criteria:
Exclusion criteria:
Cohort 2:
Inclusion Criteria:
And having at least one of these following abnormalities:
Head circumference (HC) < 2 SD, using Intergrowth curves:
(http://intergrowth21.ndog.ox.ac.uk/Newborn/en/ManualEntry) Presence of birth defects in newborn at birth (see Annex 5)
Exclusion criteria:
Cohort 3:
Inclusion Criteria:
Exclusion criteria:
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Babies born during and up to 9 months after the end of the epidemic of ZIKV within the french indies and Guyana.
3 groups : babies without any congenital abnormalities from mother with ZIKV infection, biologicaly confirmed during the pregnancy (cohort1); babies with congenital abnormalities at birth (cohort 2); babies without any congenital abnormalities from mother without ZIKV infection during the pregnancy (cohort 3)
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Hoen | Institut National de la Santé Et de la Recherche Médicale, France | Study Chair |
| Olivier Flechelles | CHU de la Martinique | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH de la Basse Terre | Basse-terre Cedex | 97109 | France | |||
| CH Andrée Rosemon (CHAR) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33472606 | Result | Grant R, Flechelles O, Tressieres B, Dialo M, Elenga N, Mediamolle N, Mallard A, Hebert JC, Lachaume N, Couchy E, Hoen B, Fontanet A. In utero Zika virus exposure and neurodevelopment at 24 months in toddlers normocephalic at birth: a cohort study. BMC Med. 2021 Jan 21;19(1):12. doi: 10.1186/s12916-020-01888-0. |
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| Head ultrasound | Other | In cohort 3, a head ultrasound will be carried in addition to the current medical practice. This exam is part of current medical practice for other groups. |
|
| Cayenne Cedex |
| 97306 |
| France |
| CHU de Martinique | FORT de France Cedex | 97261 | France |
| CHU de Pointe à Pitre/Les Abymes | Pointe à Pitre | 97139 | France |
| CH de l'Ouest Guyanais Franck Joly (CHOG) | Saint-laurent-du-maroni | 97320 | France |
| CH LC Fleming | Saint-Martin | 97054 | France |
| ID | Term |
|---|---|
| D000071243 | Zika Virus Infection |
| D008831 | Microcephaly |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D065703 | Malformations of Cortical Development, Group I |
| D054220 | Malformations of Cortical Development |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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