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

Incidence of ZIKV Infection on Fetus During the Pregnancy Clinical Trial

— ZIKA-DFA-FE  

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'année 2016

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916732
• Other study ID #: C16-08
• Secondary ID: 2016-A00399-42
• Status: Completed
• Start date: April 2016
• Est. completion date: February 2019

Study information

• Verified date: May 2022
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26980
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Incidence of ZIKV Infection on Fetus During the Pregnancy
• Infections
• Zika Virus Infection

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (2)

Funk AL, Hoen B, Vingdassalom I, Ryan C, Kadhel P, Schepers K, Gaete S, Tressières B, Fontanet A. Reassessment of the risk of birth defects due to Zika virus in Guadeloupe, 2016. PLoS Negl Trop Dis. 2021 Mar 3;15(3):e0009048. doi: 10.1371/journal.pntd.000 — View Citation

Hoen B, Schaub B, Funk AL, Ardillon V, Boullard M, Cabié A, Callier C, Carles G, Cassadou S, Césaire R, Douine M, Herrmann-Storck C, Kadhel P, Laouénan C, Madec Y, Monthieux A, Nacher M, Najioullah F, Rousset D, Ryan C, Schepers K, Stegmann-Planchard S, T — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analysis of risk factor for the occurence of congenital abnormalities		12 month
Primary	Incidence of ZIKV infection during pregnancy		12 months
Secondary	Incidence of microcephaly and other fetal abnormalities		12 month