Zika Virus Infection's Pregnancy Consequences in French Department of America (ZIKA-DFA-FE)

Institut National de la Santé Et de la Recherche Médicale, France

Status: Completed

Conditions: Incidence of ZIKV Infection on Fetus During the Pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT02916732

2016-A00399-42 (Other Identifier)

C16-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26,980 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

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

Trial design

26,980 participants in 5 patient groups

Module 1

Description:

Identification and monitoring of pregnant women who develop clinical signs of acute infection due to ZIKV (standard monitoring report)

Module 2

Description:

Monitoring of pregnant women with a suspected embryofetopathy (standard monitoring report)

Module 3

Description:

Trimester biological collection of all pregnant women during the outbreak of Zika (standard monitoring report)

Module 4

Description:

Biological collection of maternal blood and cord blood collected during the delivery

Module 5

Description:

Biological collection of maternal blood and fetal tissues of pregnant women whose pregnancies started during the outbreak of Zika , ends in an spontaneous abortion, Induced abortion or intrauterine fetal demise