Study on the Risks of Symptomatic Dengue on Pregnancy (ERiDenG)
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.
Studie Overzicht
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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-
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Saint-Pierre, Frankrijk, 97448
- Werving
- CHU de la Réunion
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Hoofdonderzoeker:
- Marine LAFONT, PH
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Case
women who contracted symptomatic dengue fever during pregnancy
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gegevensverzameling
|
|
Control
women who did not contract symptomatic dengue fever during pregnancy
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gegevensverzameling
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Evaluate the difference in the proportion of intrauterine growth retardation (IUGR) between the Case group and the Control group
Tijdsspanne: at childbirth
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Birth weight <3rd percentile according to Sentinel Network Perinatal Database : AUDIPOG
|
at childbirth
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Evaluate the difference in the proportion of prematurity between the case group and the control group
Tijdsspanne: at childbirth
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Prematurity: birth between 22 and 37 weeks of amenorrhea
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at childbirth
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Evaluate the difference in the proportion of late miscarriage between the case group and the control group
Tijdsspanne: at childbirth
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late miscarriage: Birth between 14 and 22 weeks of amenorrhea
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at childbirth
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|
Evaluate the difference in the proportion of fetal death in utero between the case group and the control group
Tijdsspanne: at childbirth
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fetal death in utero : Negative cardiac activity in utero between 14 weeks and before childbirth
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at childbirth
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Evaluate the difference in the proportion of preeclampsia between the case group and the control group
Tijdsspanne: at childbirth
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preeclampsia: Arterial hypertension> 140 and / or 90 mmHg and proteinuria / 24h> 0.3g / 24h
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at childbirth
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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
Tijdsspanne: at childbirth
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bleeding from delivery: Blood loss> 500 mL in immediate postpartum up to 2 hours postpartum
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at childbirth
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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
Tijdsspanne: at childbirth
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Birth weight <10th percentile according to Sentinel Network Perinatal Database : AUDIPOG
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at childbirth
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2020/CHU/41
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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