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

Completed

• Conditions: Incidence of ZIKV Infection on Fetus During the Pregnancy

• Registration Number: NCT02916732
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-27
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26980

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of ZIKV infection during pregnancy	12 months

Secondary Outcome Measures

Name	Time	Method
Incidence of microcephaly and other fetal abnormalities	12 month

Trial Locations

Locations (4)

CH Andrée Rosemon (CHAR); 🇫🇷 Cayenne Cedex, France

CHU de Martinique; 🇫🇷 FORT DE France Cedex, France

CHU de Pointe à Pitre/Les Abymes; 🇫🇷 Pointe A Pitre, France

CH de l'Ouest Guyanais Franck Joly (CHOG); 🇫🇷 Saint-laurent-du-maroni, France