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

Dengue Fever Clinical Trial

— ERiDenF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04822441
• Other study ID #: 2019/CHU/14
• Status: Recruiting
• Start date: March 19, 2021
• Est. completion date: March 2023

Study information

• Verified date: March 2021
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dengue
• Dengue Fever
• Fever

Intervention

Other:
• data collection
Ultrasound follow-up maternal dengue serology PCR (Polymerase Chain Reaction) and dengue serology of the umbilical cord

Locations

Country	Name	City	State
France	CHU de la Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study the teratogenic effects of the dengue virus on the fetus	Rate of fetal anomalies such as infectious fetal disease or any other fetal anomaly detected during specialized antenatal ultrasound follow-up.	at childbirth
Secondary	Study the maternal-fetal transmission of dengue fever during pregnancy	Amniotic fluid positive dengue PCR (Polymerase Chain Reaction) rate	at childbirth
Secondary	Study the maternal-fetal transmission of dengue fever in the peri-partum	Umbilical cord dengue positive and / or IgM (immunoglobulin M) positive PCR rate	at childbirth
Secondary	Study the materno-placental transmission of dengue fever during pregnancy and peri-partum	Placental dengue positive PCR rate	at childbirth
Secondary	Study the consequences at the placental level of dengue, in terms of anatomopathological alterations	Placental pathology abnormalities rate	at childbirth