Trials Sponsors Conditions Drugs Pricing

Conditions

Incidence of ZIKV Infection on Fetus During the Pregnancy

Keywords

asymptomaticsmicrocephalyabnormalities

Outcome Measures

Primary Outcomes (1)

Incidence of ZIKV infection during pregnancy
12 months

Secondary Outcomes (1)

Incidence of microcephaly and other fetal abnormalities
12 month

Other Outcomes (1)

Analysis of risk factor for the occurence of congenital abnormalities
12 month

Study Arms (5)

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

Eligibility Criteria

Age18 Years - 60 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-Probability Sample

Study Population

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.

You may qualify if:

Sponsors & Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Governmentlead

Study Sites (4)

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

Related Publications (2)

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.
PMID: 33657112RESULT
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.
PMID: 29539287RESULT

Biospecimen

Retention: SAMPLES WITH DNA

* bio-bank of serum from all pregnant women. * bio-bank of maternal blood and infant cord blood * bio-bank of maternal blood and fetal tissues

MeSH Terms

Conditions

MicrocephalyCongenital Abnormalities

Condition Hierarchy (Ancestors)

Craniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesMalformations of Cortical Development, Group IMalformations of Cortical DevelopmentNervous System MalformationsNervous System DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Enrollment

26,980 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 9 Months
Sponsor Type: OTHER GOV
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 27, 2016

Study Start

April 2016

Actual (reported)

Zika Virus Infection's Pregnancy Consequences in French Department of America

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (5)

Module 1

Module 2

Module 3

Module 4

Module 5

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Publications (2)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (5)

Module 1

Module 2

Module 3

Module 4

Module 5

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Publications (2)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations