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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02916732

Acronym

ZIKA-DFA-FE

Enrollment

26980

Registered

2016-09-27

Start date

2016-04-30

Completion date

2019-02-28

Last updated

2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incidence of ZIKV Infection on Fetus During the Pregnancy

Keywords

asymptomatics, microcephaly, abnormalities

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 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Incidence of ZIKV infection during pregnancy	12 months

Secondary

Measure	Time frame
Incidence of microcephaly and other fetal abnormalities	12 month

Other

Measure	Time frame
Analysis of risk factor for the occurence of congenital abnormalities	12 month

Countries

French Guiana, Guadeloupe, Martinique

Outcome results