An observational study in Incidence of ZIKV Infection on Fetus During the Pregnancy, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 4 sites in 3 countries. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Observational
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.
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.
22 studies on the registry are indexed under Microcephaly; 5 are open to participants now.
This study's enrollment of 26,980 is above the median of 232 across 16 observational studies indexed under Microcephaly.
Browse Microcephaly studies →Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 378 studies on the registry; 81 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
M1:
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M2:
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M3:
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M4:
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M5:
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Identification and monitoring of pregnant women who develop clinical signs of acute infection due to ZIKV (standard monitoring report)
Monitoring of pregnant women with a suspected embryofetopathy (standard monitoring report)
Trimester biological collection of all pregnant women during the outbreak of Zika (standard monitoring report)
Biological collection of maternal blood and cord blood collected during the delivery
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
Incidence of ZIKV infection during pregnancy
Time frame: 12 months
Incidence of microcephaly and other fetal abnormalities
Time frame: 12 month
Analysis of risk factor for the occurence of congenital abnormalities
Time frame: 12 month
Plan to share: No
Ran from Apr 2016 to primary completion in Feb 2019, 34 months.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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