ERiDenG: Study on the Risks of Symptomatic Dengue on Pregnancy
Study Details
Study Description
Brief 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 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Case women who contracted symptomatic dengue fever during pregnancy |
Other: data collection
data collection
|
| Control women who did not contract symptomatic dengue fever during pregnancy |
Other: data collection
data collection
|
Outcome Measures
Primary Outcome Measures
- Evaluate the difference in the proportion of intrauterine growth retardation (IUGR) between the Case group and the Control group [at childbirth]
Birth weight <3rd percentile according to Sentinel Network Perinatal Database : AUDIPOG
Secondary Outcome Measures
- Evaluate the difference in the proportion of prematurity between the case group and the control group [at childbirth]
Prematurity: birth between 22 and 37 weeks of amenorrhea
- Evaluate the difference in the proportion of late miscarriage between the case group and the control group [at childbirth]
late miscarriage: Birth between 14 and 22 weeks of amenorrhea
- Evaluate the difference in the proportion of fetal death in utero between the case group and the control group [at childbirth]
fetal death in utero : Negative cardiac activity in utero between 14 weeks and before childbirth
- Evaluate the difference in the proportion of preeclampsia between the case group and the control group [at childbirth]
preeclampsia: Arterial hypertension> 140 and / or 90 mmHg and proteinuria / 24h> 0.3g / 24h
- 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 [at childbirth]
bleeding from delivery: Blood loss> 500 mL in immediate postpartum up to 2 hours postpartum
- 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 [at childbirth]
Birth weight <10th percentile according to Sentinel Network Perinatal Database : AUDIPOG
Eligibility Criteria
Criteria
Inclusion Criteria for the case :
-
Pregnant patients
-
Major
-
Affiliated with social security
-
Symptomatic or pauci-symptomatic dengue
-
Biological confirmation of dengue fever
Inclusion Criteria for the control :
-
Pregnant patients
-
Major
-
Affiliated with social security
-
Asymptomatic
Exclusion Criteria for the 2 group :
-
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de la Réunion | Saint-Pierre | France | 97448 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de la Réunion
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020/CHU/41