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

Study Overview
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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.

Official Title
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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

Conditions
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Incidence of ZIKV Infection on Fetus During the Pregnancy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Module 1<br>Identification and monitoring of pregnant women who develop clinical signs of acute infection due to ZIKV (standard monitoring report) | |
| Module 2<br>Monitoring of pregnant women with a suspected embryofetopathy (standard monitoring report) | |
| Module 3<br>Trimester biological collection of all pregnant women during the outbreak of Zika (standard monitoring report) | |
| Module 4<br>Biological collection of maternal blood and cord blood collected during the delivery | |
| Module 5<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ZIKV infection during pregnancy |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of microcephaly and other fetal abnormalities |  | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asymptomatics, microcephaly, abnormalities