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

May 3, 2022 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

26980

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Cayenne Cedex, France, 97306
        • CH Andrée Rosemon (CHAR)
      • FORT DE France Cedex, France, 97261
        • CHU de Martinique
      • Pointe A Pitre, France, 97139
        • CHU de Pointe à Pitre/Les Abymes
      • Saint-laurent-du-maroni, France, 97320
        • CH de l'Ouest Guyanais Franck Joly (CHOG)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of ZIKV infection during pregnancy
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of microcephaly and other fetal abnormalities
Time Frame: 12 month
12 month

Other Outcome Measures

Outcome Measure
Time Frame
Analysis of risk factor for the occurence of congenital abnormalities
Time Frame: 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C16-08
  • 2016-A00399-42 (Other Identifier: France ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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