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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04822441
Acronym
ERiDenF
Enrollment
150
Registered
2021-03-30
Start date
2021-03-19
Completion date
2023-03-31
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 Fever

Keywords

dengue fever ; pregnancy

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.

Interventions

OTHERdata collection

Ultrasound follow-up maternal dengue serology PCR (Polymerase Chain Reaction) and dengue serology of the umbilical cord

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
No

Inclusion criteria

* Pregnant patients * Major * 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)

Design outcomes

Primary

MeasureTime frameDescription
Study the teratogenic effects of the dengue virus on the fetusat childbirthRate of fetal anomalies such as infectious fetal disease or any other fetal anomaly detected during specialized antenatal ultrasound follow-up.

Secondary

MeasureTime frameDescription
Study the maternal-fetal transmission of dengue fever during pregnancyat childbirthAmniotic fluid positive dengue PCR (Polymerase Chain Reaction) rate
Study the maternal-fetal transmission of dengue fever in the peri-partumat childbirthUmbilical cord dengue positive and / or IgM (immunoglobulin M) positive PCR rate
Study the materno-placental transmission of dengue fever during pregnancy and peri-partumat childbirthPlacental dengue positive PCR rate
Study the consequences at the placental level of dengue, in terms of anatomopathological alterationsat childbirthPlacental pathology abnormalities rate

Countries

France

Outcome results

None listed

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