Clinical trial NCT04822441: Prospective Study on the Risks of Dengue Fever for the Fetus.
Official title: Prospective Study on the Risks of Dengue Fever for the Fetus.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dengue Fever
Keywords: dengue fever ; pregnancy
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who contracted dengue fever during 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Study the teratogenic effects of the dengue virus on the fetus
timeFrame: at childbirth
Secondary outcomes:
measure: Study the maternal-fetal transmission of dengue fever during pregnancy
timeFrame: at childbirth
measure: Study the maternal-fetal transmission of dengue fever in the peri-partum
timeFrame: at childbirth
measure: Study the materno-placental transmission of dengue fever during pregnancy and peri-partum
timeFrame: at childbirth
measure: Study the consequences at the placental level of dengue, in terms of anatomopathological alterations
timeFrame: at childbirth
Other outcomes:
Locations:
city: Saint-Pierre
country: France
facility: CHU de la Réunion
Study officials:
References: