- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02916732
Zika Virus Infection's Pregnancy Consequences in French Department of America (ZIKA-DFA-FE)
Études Observationnelles Des conséquences de l'Infection à Virus Zika au Cours de la Grossesse Pendant l'épidémie Des départements français d'Amérique de l'année 2016
Studieoversigt
Status
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
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Cayenne Cedex, Frankrig, 97306
- CH Andrée Rosemon (CHAR)
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FORT DE France Cedex, Frankrig, 97261
- CHU de Martinique
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Pointe A Pitre, Frankrig, 97139
- CHU de Pointe à Pitre/Les Abymes
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Saint-laurent-du-maroni, Frankrig, 97320
- CH de l'Ouest Guyanais Franck Joly (CHOG)
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
M1:
Inclusion Criteria:
- On-going pregnancy regardless the presumed date of birth
- Clinical signs suggestive of ZIKV infection
- Whatever the RT-PCR analysis
Exclusion Criteria:
- Minor
- No consent
M2:
Inclusion Criteria:
- Head circumference < 5th percentile
- Other brain morphological abnormality
- Hydramnios
- Intrauterine growth restriction (IUGR)
Exclusion Criteria:
- Minor
- No consent
M3:
Inclusion Criteria:
- Pregnant woman during epidemic period of ZIKV
Exclusion Criteria:
- Minor
- Opposition
M4:
Inclusion Criteria:
- Delivery during epidemic period of ZIKV
Exclusion Criteria:
- Minor
- No consent
M5:
Inclusion Criteria:
- Spontaneous abortion or fetal death in utero during epidemic period of ZIKV
Exclusion Criteria:
- Minor
- No consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Incidence of ZIKV infection during pregnancy
Tidsramme: 12 months
|
12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Incidence of microcephaly and other fetal abnormalities
Tidsramme: 12 month
|
12 month
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Analysis of risk factor for the occurence of congenital abnormalities
Tidsramme: 12 month
|
12 month
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C16-08
- 2016-A00399-42 (Anden identifikator: France ANSM)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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