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

• ClinicalTrials.gov Identifier: NCT02916732
• Recruitment Status: Completed
• First Posted: September 27, 2016
• Last Update Posted: May 6, 2022
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Information provided by (Responsible Party): Institut National de la Santé Et de la Recherche Médicale, France

Study Description

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.

Condition or disease
Incidence of ZIKV Infection on Fetus During the 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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 26980 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 9 Months
• 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
• Actual Study Start Date: April 2016
• Actual Primary Completion Date: February 2019
• Actual Study Completion Date: February 2019

Groups and Cohorts

Group/Cohort
Module 1; Identification and monitoring of pregnant women who develop clinical signs of acute infection due to ZIKV (standard monitoring report)
Module 2; Monitoring of pregnant women with a suspected embryofetopathy (standard monitoring report)
Module 3; Trimester biological collection of all pregnant women during the outbreak of Zika (standard monitoring report)
Module 4; Biological collection of maternal blood and cord blood collected during the delivery
Module 5; 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

Outcome Measures

Primary Outcome Measures :

1. Incidence of ZIKV infection during pregnancy [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. Incidence of microcephaly and other fetal abnormalities [ Time Frame: 12 month ]

Other Outcome Measures:

1. Analysis of risk factor for the occurence of congenital abnormalities [ Time Frame: 12 month ]

Biospecimen Retention:   Samples With DNA

• bio-bank of serum from all pregnant women.
• bio-bank of maternal blood and infant cord blood
• bio-bank of maternal blood and fetal tissues

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

The population of this study is women who have been pregnant during the 2016 ZIKV Epidemic in the DFAs. Five study arms (hereafter called 'modules') have been defined with various inclusion criteria for each module.

M1: Pregnant women with clinical signs of acute ZIKV infection

Module 2: Pregnant women for which an abnormality has been detected in the fetus.

Module 3: Bio-bank of serum, collected once per trimester, from all pregnant women.

Module 4: Bio-bank of maternal blood and infant cord blood, taken the day of birth in all mothers and their babies in the 3 DFAs.

Module 5: Bio-bank of maternal blood and fetal tissues from women in whom the pregnancy was terminated due to miscarriage, abortion on medical grounds, or a fetal death in-utero.

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

Contacts and Locations

Locations

France

CH Andrée Rosemon (CHAR)

Cayenne Cedex, France, 97306

CHU de Martinique

FORT DE France Cedex, France, 97261

CHU de Pointe à Pitre/Les Abymes

Pointe A Pitre, France, 97139

CH de l'Ouest Guyanais Franck Joly (CHOG)

Saint-laurent-du-maroni, France, 97320

Sponsors and Collaborators

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

More Information

Additional Information:

Publications of Results:

Funk AL, Hoen B, Vingdassalom I, Ryan C, Kadhel P, Schepers K, Gaete S, Tressieres 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.0009048. eCollection 2021 Mar.

Hoen B, Schaub B, Funk AL, Ardillon V, Boullard M, Cabie A, Callier C, Carles G, Cassadou S, Cesaire R, Douine M, Herrmann-Storck C, Kadhel P, Laouenan C, Madec Y, Monthieux A, Nacher M, Najioullah F, Rousset D, Ryan C, Schepers K, Stegmann-Planchard S, Tressieres B, Volumenie JL, Yassinguezo S, Janky E, Fontanet A. Pregnancy Outcomes after ZIKV Infection in French Territories in the Americas. N Engl J Med. 2018 Mar 15;378(11):985-994. doi: 10.1056/NEJMoa1709481.

• Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
• ClinicalTrials.gov Identifier: NCT02916732
• Other Study ID Numbers: C16-08; 2016-A00399-42 ( Other Identifier: France ANSM )
• First Posted: September 27, 2016
• Last Update Posted: May 6, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:

asymptomatics; microcephaly; abnormalities

Additional relevant MeSH terms:

Infections; Zika Virus Infection; Arbovirus Infections; Vector Borne Diseases; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections