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.
Studieöversikt
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
-
Saint-Pierre, Frankrike, 97448
- Rekrytering
- CHU de la Réunion
-
Huvudutredare:
- Marine LAFONT, PH
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Case
women who contracted symptomatic dengue fever during pregnancy
|
datainsamling
|
|
Control
women who did not contract symptomatic dengue fever during pregnancy
|
datainsamling
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluate the difference in the proportion of intrauterine growth retardation (IUGR) between the Case group and the Control group
Tidsram: at childbirth
|
Birth weight <3rd percentile according to Sentinel Network Perinatal Database : AUDIPOG
|
at childbirth
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluate the difference in the proportion of prematurity between the case group and the control group
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: at childbirth
|
Birth weight <10th percentile according to Sentinel Network Perinatal Database : AUDIPOG
|
at childbirth
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2020/CHU/41
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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