DengueERiDenGNCT04826081
Study on the Risks of Symptomatic Dengue on Pregnancy
An observational study of Dengue and Pregnancy, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
Dengue fever is the most common arbovirus worldwide (390 million people infected per year) and is a global public health problem. This public health problem is also becoming European due to its rapid expansion over the past decade with an increase in cases of 400% and the appearance of the first indigenous cases of… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- data collection
- How many people
- 336 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2021to Mar 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Case : Patients who contracted dengue fever during pregnancy Control : Patient who does not get 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
- Pregnant patients
Show all 9Show fewer
- Major
- Affiliated with social security
- Asymptomatic
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, 0262359949 ext. +262, lucie.auzanneau@chu-reunion.fr
Marine LAFONT, PH
About this study
Official title: Prospective Study on the Risks of Symptomatic Dengue on Pregnancy
Dengue fever is the most common arbovirus worldwide (390 million people infected per year) and is a global public health problem. This public health problem is also becoming European due to its rapid expansion over the past decade with an increase in cases of 400% and the appearance of the first indigenous cases of dengue in Europe. Studies on the consequences of dengue fever on pregnancy find contradictory results. In fact, most of these studies are observational studies describing the risk of dengue fever for pregnancy, without comparison with a control group or comparing the different pregnancy morbidities to those found during pregnancy in the general population. Other research is retrospective case-control studies with major biases in the definitions of obstetric complications, which makes the results questionable.
The study therefore proposes to carry out a prospective case-control study with rigorous matching criteria, strict definitions of cases, controls and obstetric complications.
- 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
data collection
| Study group | Role | What they receive |
|---|---|---|
| Case | women who contracted symptomatic dengue fever during pregnancy Receives: Other: data collection | |
| Control | women who did not contract symptomatic dengue fever during pregnancy Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the difference in the proportion of intrauterine growth retardation (IUGR) between the Case group and the Control group
Birth weight <3rd percentile according to Sentinel Network Perinatal Database : AUDIPOG
Measured: at childbirth
Secondary outcomes (6)
Evaluate the difference in the proportion of prematurity between the case group and the control group
Prematurity: birth between 22 and 37 weeks of amenorrhea
Measured: at childbirth
Evaluate the difference in the proportion of late miscarriage between the case group and the control group
late miscarriage: Birth between 14 and 22 weeks of amenorrhea
Measured: at childbirth
Evaluate the difference in the proportion of fetal death in utero between the case group and the control group
fetal death in utero : Negative cardiac activity in utero between 14 weeks and before childbirth
Measured: at childbirth
Evaluate the difference in the proportion of preeclampsia between the case group and the control group
preeclampsia: Arterial hypertension> 140 and / or 90 mmHg and proteinuria / 24h> 0.3g / 24h
Measured: at childbirth
Evaluate the difference in the proportion of bleeding from delivery between the case group and the control group between the case group and the control group
bleeding from delivery: Blood loss> 500 mL in immediate postpartum up to 2 hours postpartum
Measured: at childbirth
Evaluate the difference in the proportion of small weight for gestational age between the case group and the control group between the case group and the control group
Birth weight <10th percentile according to Sentinel Network Perinatal Database : AUDIPOG
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 posted1 Apr 2021
- Study start15 Jun 2021
- Primary completionJan 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies 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
- 336 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
- NCT04826081
- Sponsor's protocol ID
- 2020/CHU/41
- Acronym
- ERiDenG
- Status last verified
- Nov 2021
- First submitted
- 30 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 Symptomatic Dengue on Pregnancy
- ClinicalTrials.gov ID
- NCT04826081
- Acronym / sponsor ID
- ERiDenG / 2020/CHU/41
- Keywords
- dengue fever ; pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 1 Apr 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 fever is the most common arbovirus worldwide (390 million people infected per year) and is a global public health problem. This public health problem is also becoming European due to its rapid expansion over the past decade with an increase in cases of 400% and the appearance of the first indigenous cases of dengue in Europe. Studies on the consequences of dengue fever on pregnancy find contradictory results. In fact, most of these studies are observational studies describing the risk of dengue fever for pregnancy, without comparison with a control group or comparing the different pregnancy morbidities to those found during pregnancy in the general population. Other research is retrospective case-control studies with major biases in the definitions of obstetric complications, which makes the results questionable.
The study therefore proposes to carry out a prospective case-control study with rigorous matching criteria, strict definitions of cases, controls and obstetric complications.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: data collectionwomen who contracted symptomatic dengue fever during pregnancy |
| Control | – | Other: data collectionwomen who did not contract symptomatic dengue fever during pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Case : Patients who contracted dengue fever during pregnancy Control : Patient who does not get dengue fever during pregnancy
Key inclusion criteria (9 listed)
- Pregnant patients
- Major
- Affiliated with social security
- Symptomatic or pauci-symptomatic dengue
- Biological confirmation of dengue fever
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 collectiondata collection | Other | Case, Control |
Primary outcome
Evaluate the difference in the proportion of intrauterine growth retardation (IUGR) between the Case group and the Control group
Time frame: at childbirth
Birth weight <3rd percentile according to Sentinel Network Perinatal Database : AUDIPOG
6 secondary outcomes
Evaluate the difference in the proportion of prematurity between the case group and the control group
Time frame: at childbirth
Evaluate the difference in the proportion of late miscarriage between the case group and the control group
Time frame: at childbirth
Evaluate the difference in the proportion of fetal death in utero between the case group and the control group
Time frame: at childbirth
Evaluate the difference in the proportion of preeclampsia between the case group and the control group
Time frame: at childbirth
Evaluate the difference in the proportion of bleeding from delivery between the case group and the control group between the case group and the control group
Time frame: at childbirth
Evaluate the difference in the proportion of small weight for gestational age between the case group and the control group between the case group and the control group
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 and Pregnancy, 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 9 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?
Contact Lucie AUZANNEAU (0262359949 ext. +262, lucie.auzanneau@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the difference in the proportion of intrauterine growth retardation (IUGR) between the Case group and the Control group (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.