An observational study in Zika Virus Infection on Fetus and Child During the Pregnancy, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 6 sites in 4 countries. Open to participants aged 0 Days to 2 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Observational
The Zika 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 (including imaging and laboratory results) as well as biological samples allowing the precise description of the consequences of ZIKV infection during pregnancy.
This study is the 2nd arm of a global research program in the 3 French Overseas Departments in the Caribbean. It is complementary to the first arm (ZIKA-DFA-FE) consisting in the follow-up of women in the French Overseas Departments who are pregnant during the Zika epidemic period.
The study population is made up of infants born during and up to 9 months after the end of the Zika epidemic period in the French Overseas Departments.
The data and biological specimens collected for this project will be done so through the recommended standard of care which has been put in place considering the ZIKV epidemic in the 3 French Overseas Departments, upholding existing recommendations (profession and/or recommendation from the public health authorities)
At birth (from Day 0 to Day 4):
Follow-up from Day 4 to 2 years:
- Clinical examination focusing on neuropsychomotor development at the 2nd, 4th, 9th, 18th and 24th month.
63 studies on the registry are indexed under Zika Virus Infection; 5 are open to participants now.
This study's enrollment of 1,180 is above the median of 600 across 24 observational studies indexed under Zika Virus Infection.
Browse Zika Virus Infection studies →Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 375 studies on the registry; 82 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Babies born during and up to 9 months after the end of the epidemic of ZIKV within the french indies and Guyana.
3 groups : babies without any congenital abnormalities from mother with ZIKV infection, biologicaly confirmed during the pregnancy (cohort1); babies with congenital abnormalities at birth (cohort 2); babies without any congenital abnormalities from mother without ZIKV infection during the pregnancy (cohort 3)
Cohort 1:
Inclusion criteria:
Exclusion criteria:
Cohort 2:
Inclusion Criteria:
And having at least one of these following abnormalities:
Head circumference (HC) \< 2 SD, using Intergrowth curves:
(http://intergrowth21.ndog.ox.ac.uk/Newborn/en/ManualEntry) Presence of birth defects in newborn at birth (see Annex 5)
Exclusion criteria:
Cohort 3:
Inclusion Criteria:
Exclusion criteria:
Monitoring of children born without congenital anomalies to mothers with biologically confirmed ZIKV's infection during the pregnancy
Monitoring of children born with congenital anomalies to mothers with biologically confirmed ZIKV's infection during the pregnancy
Monitoring of children born without congenital anomalies to mothers with no biologically confirmed ZIKV's infection during the pregnancy
Other: fundus examination · Other: Head ultrasound
In cohort 3, a fundus examination will be carried in addition to the current medical practice. This exam is part of current medical practice for other groups.
In cohort 3, a head ultrasound will be carried in addition to the current medical practice. This exam is part of current medical practice for other groups.
Embryofoetopathy incidence within cohort 1 and 3
incidence comparison between the 2 groups and the calcul of adjusted incidence ratios
Time frame: 24 months
Comparison of congenital abnormality incidence rates between cohorts 1 and 3
* Whether or not the mother was symptomatic for ZIKV infection during pregnancy * Gestational age at the moment of ZIKV infection * The level of ZIKV viremia at the moment of acute ZIKV infection
Time frame: 24 months
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Institut National de la Santé Et de la Recherche Médicale, France