Incidence of ZIKV Infection on Fetus During the PregnancyZIKA-DFA-FENCT02916732
Zika Virus Infection's Pregnancy Consequences in French Department of America
An observational study of Incidence of ZIKV Infection on Fetus During the Pregnancy, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incidence of ZIKV Infection on Fetus During the Pregnancy
- How many people
- 26,980 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Apr 2016to Feb 2019
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- On-going pregnancy regardless the presumed date of birth
- Clinical signs suggestive of ZIKV infection
- Whatever the RT-PCR analysis
- Head circumference < 5th percentile
- Other brain morphological abnormality
- Hydramnios
Show all 10Show fewer
- Intrauterine growth restriction (IUGR)
- Pregnant woman during epidemic period of ZIKV
- Delivery during epidemic period of ZIKV
- Spontaneous abortion or fetal death in utero during epidemic period of ZIKV
Who cannot join
- Minor
- No consent
- M2:
- Minor
- No consent
- M3:
Show all 14Show fewer
- Minor
- Opposition
- M4:
- Minor
- No consent
- M5:
- Minor
- No consent
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
French Guiana2 sites
CH Andrée Rosemon (CHAR)
Cayenne
CH de l'Ouest Guyanais Franck Joly (CHOG)
Saint-Laurent-du-Maroni
About this study
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
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.
Read the 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.
- Keywords
- asymptomatics, microcephaly, abnormalities
- Medical subject headings
- Microcephaly, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ZIKV infection during pregnancy
Measured: 12 months
Secondary outcomes (1)
Incidence of microcephaly and other fetal abnormalities
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Incidence of ZIKV Infection on Fetus During the PregnancyStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26,980 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916732
- Sponsor's protocol ID
- C16-08
- Other IDs
- 2016-A00399-42
- Acronym
- ZIKA-DFA-FE
- Status last verified
- May 2022
- First submitted
- 26 Sep 2016
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33657112Hoen 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.
PubMed 29539287
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02916732
- Acronym / sponsor ID
- ZIKA-DFA-FE / C16-08
- Keywords
- asymptomatics, microcephaly, abnormalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26,980 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Apr 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (10 listed)
- On-going pregnancy regardless the presumed date of birth
- Clinical signs suggestive of ZIKV infection
- Whatever the RT-PCR analysis
- Head circumference < 5th percentile
- Other brain morphological abnormality
Key exclusion criteria (14 listed)
- Minor
- No consent
- Minor
- No consent
- Minor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of ZIKV infection during pregnancy
Time frame: 12 months
1 secondary outcome
Incidence of microcephaly and other fetal abnormalities
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 33657112Funk 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.
- Results publication: PubMed 29539287Hoen 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incidence of ZIKV Infection on Fetus During the Pregnancy, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in French Guiana, Guadeloupe, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ZIKV infection during pregnancy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02916732, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.