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

NCT ID: NCT02916732

Last Updated: 2025-12-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

26980 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Incidence of ZIKV Infection on Fetus During the Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* On-going pregnancy regardless the presumed date of birth
* 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

* Minor
* No consent

M2:


* Minor
* No consent

M3:


* Minor
* Opposition

M4:


* Minor
* No consent

M5:


* Minor
* No consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CH Andrée Rosemon (CHAR)

Cayenne, , French Guiana

Site Status

CH de l'Ouest Guyanais Franck Joly (CHOG)

Saint-Laurent-du-Maroni, , French Guiana

Site Status

CHU de Pointe à Pitre/Les Abymes

Pointe-à-Pitre, , Guadeloupe

Site Status

CHU de Martinique

Fort-de-France, , Martinique

Site Status

Countries

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French Guiana Guadeloupe Martinique

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.

Reference Type RESULT
PMID: 33657112 (View on PubMed)

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.

Reference Type RESULT
PMID: 29539287 (View on PubMed)

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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