Skip to content

Study on the Risks of Symptomatic Dengue on Pregnancy

Prospective Study on the Risks of Symptomatic Dengue on Pregnancy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04826081
Acronym
ERiDenG
Enrollment
336
Registered
2021-04-01
Start date
2021-06-15
Completion date
2024-03-31
Last updated
2021-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue, Pregnancy

Keywords

dengue fever ; pregnancy

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.

Interventions

OTHERdata collection

data collection

Sponsors

Centre Hospitalier Universitaire de la Réunion
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the difference in the proportion of intrauterine growth retardation (IUGR) between the Case group and the Control groupat childbirthBirth weight \<3rd percentile according to Sentinel Network Perinatal Database : AUDIPOG

Secondary

MeasureTime frameDescription
Evaluate the difference in the proportion of late miscarriage between the case group and the control groupat childbirthlate 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 groupat childbirthfetal death in utero : Negative cardiac activity in utero between 14 weeks and before childbirth
Evaluate the difference in the proportion of prematurity between the case group and the control groupat childbirthPrematurity: birth between 22 and 37 weeks of amenorrhea
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 groupat childbirthbleeding 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 groupat childbirthBirth weight \<10th percentile according to Sentinel Network Perinatal Database : AUDIPOG
Evaluate the difference in the proportion of preeclampsia between the case group and the control groupat childbirthpreeclampsia: Arterial hypertension\> 140 and / or 90 mmHg and proteinuria / 24h\> 0.3g / 24h

Countries

France

Contacts

Primary ContactLucie AUZANNEAU
lucie.auzanneau@chu-reunion.fr0262359949

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026