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.
Studieoversikt
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
-
Saint-Pierre, Frankrike, 97448
- Rekruttering
- CHU de la Réunion
-
Hovedetterforsker:
- Marine LAFONT, PH
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Case
women who contracted symptomatic dengue fever during pregnancy
|
datainnsamling
|
|
Control
women who did not contract symptomatic dengue fever during pregnancy
|
datainnsamling
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluate the difference in the proportion of intrauterine growth retardation (IUGR) between the Case group and the Control group
Tidsramme: at childbirth
|
Birth weight <3rd percentile according to Sentinel Network Perinatal Database : AUDIPOG
|
at childbirth
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluate the difference in the proportion of prematurity between the case group and the control group
Tidsramme: at childbirth
|
Prematurity: birth between 22 and 37 weeks of amenorrhea
|
at childbirth
|
|
Evaluate the difference in the proportion of late miscarriage between the case group and the control group
Tidsramme: at childbirth
|
late miscarriage: Birth between 14 and 22 weeks of amenorrhea
|
at childbirth
|
|
Evaluate the difference in the proportion of fetal death in utero between the case group and the control group
Tidsramme: at childbirth
|
fetal death in utero : Negative cardiac activity in utero between 14 weeks and before childbirth
|
at childbirth
|
|
Evaluate the difference in the proportion of preeclampsia between the case group and the control group
Tidsramme: at childbirth
|
preeclampsia: Arterial hypertension> 140 and / or 90 mmHg and proteinuria / 24h> 0.3g / 24h
|
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
Tidsramme: at childbirth
|
bleeding from delivery: Blood loss> 500 mL in immediate postpartum up to 2 hours postpartum
|
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
Tidsramme: at childbirth
|
Birth weight <10th percentile according to Sentinel Network Perinatal Database : AUDIPOG
|
at childbirth
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2020/CHU/41
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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