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Study on the Risks of Symptomatic Dengue on Pregnancy (ERiDenG)

C

Centre Hospitalier Universitaire de la Réunion

Status

Unknown

Conditions

Dengue
Pregnancy

Treatments

Other: data collection

Study type

Observational

Funder types

Other

Identifiers

NCT04826081
2020/CHU/41

Details and patient eligibility

About

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.

Enrollment

336 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

336 participants in 2 patient groups

Case
Description:
women who contracted symptomatic dengue fever during pregnancy
Treatment:
Other: data collection
Control
Description:
women who did not contract symptomatic dengue fever during pregnancy
Treatment:
Other: data collection

Trial contacts and locations

1

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Central trial contact

Lucie AUZANNEAU

Data sourced from clinicaltrials.gov

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