Dengue FeverERiDenFNCT04822441
Prospective Study on the Risks of Dengue Fever for the Fetus.
An observational study of Dengue Fever, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
Dengue is the most common arbovirus worldwide (390 million people infected each year) and belongs to the Flavivirus genus of the Flaviviridae family like Zika. Its expansion has been rapid since the last decade with an increase in the number of cases of 400% and the first cases of indigenous dengue described in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dengue Fever
- What is being tested?
- data collection
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2021to Mar 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who contracted dengue fever during pregnancy
Who may be able to join
- Pregnant patients
- Major
- Affiliated with social security
- Symptomatic or pauci-symptomatic dengue
- Biological confirmation of dengue fever by dengue positive PCR or IgM positive during the current dengue episode
Who cannot join
- Multiple pregnancy
- Patient's refusal
- Protected persons: person deprived of liberty by judicial or administrative decision, minor, and person subject to a legal protection measure: guardianship or curators)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de la Réunion
Saint-Pierre, 97448
Lucie AUZANNEAU, +262 (0) 262 35 99 49, lucie.auzanneau@chu-reunion.fr
Marine LAFONT, PH
About this study
Dengue is the most common arbovirus worldwide (390 million people infected each year) and belongs to the Flavivirus genus of the Flaviviridae family like Zika. Its expansion has been rapid since the last decade with an increase in the number of cases of 400% and the first cases of indigenous dengue described in Europe.
Current data on the consequences of dengue fever on the fetus are incomplete. The risk of maternal-fetal transmission of dengue during the peripartum period has now been recorded in numerous case reports and a few case series for patients who contracted dengue in the 12 days preceding childbirth or at the time of delivery. However, the transmission of dengue is highly variable depending on the studies ranging from 1.6 to 15% and the consequences for the newborn are very variable ranging from simple thrombocytopenia to death in severe neonatal dengue.
Regarding the risk of malformation, a few old cases of heart disease, hydrocephalus and neural tube closure abnormalities have been described in the literature following exposure to dengue fever during pregnancy. Since no malformative case has been described, however, to our knowledge, no prospective study with specialized ultrasound monitoring has been performed for pregnant women who contracted dengue during their pregnancy.
- Conditions
- Dengue Fever
- Being tested
- data collection
- Keywords
- dengue fever ; pregnancy
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
Ultrasound follow-up maternal dengue serology PCR (Polymerase Chain Reaction) and dengue serology of the umbilical cord
| Study group | Role | What they receive |
|---|---|---|
| Patients who contracted dengue fever before 34 weeks of amenorrhea | Patients who contracted biologically proven dengue fever during pregnancy before 34 weeks outside the peri-partum period (more than 12 days before childbirth) Receives: Other: data collection | |
| Patients who contracted dengue fever after 34 weeks of amenorrhea | Patients who contracted biologically proven dengue fever during pregnancy after 34 weeks outside the peri-partum period (more than 12 days before childbirth) Receives: Other: data collection | |
| Patients who have contracted dengue during the peripartum period | Patients who have contracted dengue during the peripartum period or who have a suspicion of dengue (in the 12 days preceding childbirth) Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the teratogenic effects of the dengue virus on the fetus
Rate of fetal anomalies such as infectious fetal disease or any other fetal anomaly detected during specialized antenatal ultrasound follow-up.
Measured: at childbirth
Secondary outcomes (4)
Study the maternal-fetal transmission of dengue fever during pregnancy
Amniotic fluid positive dengue PCR (Polymerase Chain Reaction) rate
Measured: at childbirth
Study the maternal-fetal transmission of dengue fever in the peri-partum
Umbilical cord dengue positive and / or IgM (immunoglobulin M) positive PCR rate
Measured: at childbirth
Study the materno-placental transmission of dengue fever during pregnancy and peri-partum
Placental dengue positive PCR rate
Measured: at childbirth
Study the consequences at the placental level of dengue, in terms of anatomopathological alterations
Placental pathology abnormalities rate
Measured: at childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start19 Mar 2021
- Primary completionJan 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822441
- Sponsor's protocol ID
- 2019/CHU/14
- Acronym
- ERiDenF
- Status last verified
- Mar 2021
- First submitted
- 26 Mar 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Risks of Dengue Fever for the Fetus.
- ClinicalTrials.gov ID
- NCT04822441
- Acronym / sponsor ID
- ERiDenF / 2019/CHU/14
- Conditions
- Dengue Fever
- Keywords
- dengue fever ; pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 30 Mar 2021 (actual)
- 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.
Dengue is the most common arbovirus worldwide (390 million people infected each year) and belongs to the Flavivirus genus of the Flaviviridae family like Zika. Its expansion has been rapid since the last decade with an increase in the number of cases of 400% and the first cases of indigenous dengue described in Europe.
Current data on the consequences of dengue fever on the fetus are incomplete. The risk of maternal-fetal transmission of dengue during the peripartum period has now been recorded in numerous case reports and a few case series for patients who contracted dengue in the 12 days preceding childbirth or at the time of delivery. However, the transmission of dengue is highly variable depending on the studies ranging from 1.6 to 15% and the consequences for the newborn are very variable ranging from simple thrombocytopenia to death in severe neonatal dengue.
Regarding the risk of malformation, a few old cases of heart disease, hydrocephalus and neural tube closure abnormalities have been described in the literature following exposure to dengue fever during pregnancy. Since no malformative case has been described, however, to our knowledge, no prospective study with specialized ultrasound monitoring has been performed for pregnant women who contracted dengue during their pregnancy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients who contracted dengue fever before 34 weeks of amenorrhea | – | Other: data collectionPatients who contracted biologically proven dengue fever during pregnancy before 34 weeks outside the peri-partum period (more than 12 days before childbirth) |
| Patients who contracted dengue fever after 34 weeks of amenorrhea | – | Other: data collectionPatients who contracted biologically proven dengue fever during pregnancy after 34 weeks outside the peri-partum period (more than 12 days before childbirth) |
| Patients who have contracted dengue during the peripartum period | – | Other: data collectionPatients who have contracted dengue during the peripartum period or who have a suspicion of dengue (in the 12 days preceding childbirth) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who contracted dengue fever during pregnancy
Key inclusion criteria (5 listed)
- Pregnant patients
- Major
- Affiliated with social security
- Symptomatic or pauci-symptomatic dengue
- Biological confirmation of dengue fever by dengue positive PCR or IgM positive during the current dengue episode
Key exclusion criteria (3 listed)
- Multiple pregnancy
- Patient's refusal
- Protected persons: person deprived of liberty by judicial or administrative decision, minor, and person subject to a legal protection measure: guardianship or curators)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectionUltrasound follow-up maternal dengue serology PCR (Polymerase Chain Reaction) and dengue serology of the umbilical cord | Other | Patients who contracted dengue fever after 34 weeks of amenorrhea, Patients who contracted dengue fever before 34 weeks of amenorrhea, Patients who have contracted dengue during the peripartum period |
Primary outcome
Study the teratogenic effects of the dengue virus on the fetus
Time frame: at childbirth
Rate of fetal anomalies such as infectious fetal disease or any other fetal anomaly detected during specialized antenatal ultrasound follow-up.
4 secondary outcomes
Study the maternal-fetal transmission of dengue fever during pregnancy
Time frame: at childbirth
Study the maternal-fetal transmission of dengue fever in the peri-partum
Time frame: at childbirth
Study the materno-placental transmission of dengue fever during pregnancy and peri-partum
Time frame: at childbirth
Study the consequences at the placental level of dengue, in terms of anatomopathological alterations
Time frame: at childbirth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue Fever, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the teratogenic effects of the dengue virus on the fetus (time frame: at childbirth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2021.