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Completed

NCT Number: NCT02916732

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

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.

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Key information

Conditions

Incidence of ZIKV Infection on Fetus During the Pregnancy Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Malformations of Cortical Development Malformations of Cortical Development, Group I Microcephaly Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Nervous System Malformations

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

CH Andrée Rosemon (CHAR), Cayenne, French Guiana

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of ZIKV infection during pregnancy

    Time frame: 12 months

Secondary outcomes

  1. Incidence of microcephaly and other fetal abnormalities

    Time frame: 12 month

Other outcomes

  1. Analysis of risk factor for the occurence of congenital abnormalities

    Time frame: 12 month

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study 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

Acronym: ZIKA-DFA-FE

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2016
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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