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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: 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'ann&

Brief 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 Summary: 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.
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Current Primary Outcome: Incidence of ZIKV infection during pregnancy [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of microcephaly and other fetal abnormalities [ Time Frame: 12 month ]

Original Secondary Outcome: Same as current

Information By: Institut National de la Santé Et de la Recherche Médicale, France

Dates:
Date Received: September 26, 2016
Date Started: April 2016
Date Completion: January 2019
Last Updated: September 26, 2016
Last Verified: April 2016