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Clinical Trials/NCT04822441
NCT04822441
Unknown
Not Applicable

Prospective Study on the Risks of Dengue Fever for the Fetus.

Centre Hospitalier Universitaire de la Réunion1 site in 1 country150 target enrollmentMarch 19, 2021
ConditionsDengue Fever

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dengue Fever
Sponsor
Centre Hospitalier Universitaire de la Réunion
Enrollment
150
Locations
1
Primary Endpoint
Study the teratogenic effects of the dengue virus on the fetus
Last Updated
4 years ago

Overview

Brief Summary

Dengue is the most common arbovirus worldwide (390 million people infected each year) and belongs to the Flavivirus genus of the Flaviviridae family like Zika. Its expansion has been rapid since the last decade with an increase in the number of cases of 400% and the first cases of indigenous dengue described in Europe.

Current data on the consequences of dengue fever on the fetus are incomplete. The risk of maternal-fetal transmission of dengue during the peripartum period has now been recorded in numerous case reports and a few case series for patients who contracted dengue in the 12 days preceding childbirth or at the time of delivery. However, the transmission of dengue is highly variable depending on the studies ranging from 1.6 to 15% and the consequences for the newborn are very variable ranging from simple thrombocytopenia to death in severe neonatal dengue.

Regarding the risk of malformation, a few old cases of heart disease, hydrocephalus and neural tube closure abnormalities have been described in the literature following exposure to dengue fever during pregnancy. Since no malformative case has been described, however, to our knowledge, no prospective study with specialized ultrasound monitoring has been performed for pregnant women who contracted dengue during their pregnancy.

Registry
clinicaltrials.gov
Start Date
March 19, 2021
End Date
March 2023
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Pregnant patients
  • Affiliated with social security
  • Symptomatic or pauci-symptomatic dengue
  • Biological confirmation of dengue fever by dengue positive PCR or IgM positive during the current dengue episode

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

Study the teratogenic effects of the dengue virus on the fetus

Time Frame: at childbirth

Rate of fetal anomalies such as infectious fetal disease or any other fetal anomaly detected during specialized antenatal ultrasound follow-up.

Secondary Outcomes

  • Study the maternal-fetal transmission of dengue fever during pregnancy(at childbirth)
  • Study the materno-placental transmission of dengue fever during pregnancy and peri-partum(at childbirth)
  • Study the maternal-fetal transmission of dengue fever in the peri-partum(at childbirth)
  • Study the consequences at the placental level of dengue, in terms of anatomopathological alterations(at childbirth)

Study Sites (1)

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