NCT02916732

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26,980 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

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

• Incidence of ZIKV Infection on Fetus During the Pregnancy

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2016-09-27
• Last updated: 2025-12-04

Locations

4 sites across 3 countries: French Guiana, Guadeloupe, Martinique