Prospective Study on the Risks of Dengue Fever for the Fetus.
- Conditions
- Dengue Fever
- Interventions
- Other: data collection
- Registration Number
- NCT04822441
- Lead Sponsor
- Centre Hospitalier Universitaire de la Réunion
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 150
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients who have contracted dengue during the peripartum period data collection Patients who have contracted dengue during the peripartum period or who have a suspicion of dengue (in the 12 days preceding childbirth) Patients who contracted dengue fever before 34 weeks of amenorrhea data collection Patients who contracted biologically proven dengue fever during pregnancy before 34 weeks outside the peri-partum period (more than 12 days before childbirth) Patients who contracted dengue fever after 34 weeks of amenorrhea data collection Patients who contracted biologically proven dengue fever during pregnancy after 34 weeks outside the peri-partum period (more than 12 days before childbirth)
- Primary Outcome Measures
Name Time Method Study the teratogenic effects of the dengue virus on the fetus at childbirth Rate of fetal anomalies such as infectious fetal disease or any other fetal anomaly detected during specialized antenatal ultrasound follow-up.
- Secondary Outcome Measures
Name Time Method Study the maternal-fetal transmission of dengue fever during pregnancy at childbirth Amniotic fluid positive dengue PCR (Polymerase Chain Reaction) rate
Study the materno-placental transmission of dengue fever during pregnancy and peri-partum at childbirth Placental dengue positive PCR rate
Study the maternal-fetal transmission of dengue fever in the peri-partum at childbirth Umbilical cord dengue positive and / or IgM (immunoglobulin M) positive PCR rate
Study the consequences at the placental level of dengue, in terms of anatomopathological alterations at childbirth Placental pathology abnormalities rate
Trial Locations
- Locations (1)
CHU de la Réunion
🇫🇷Saint-Pierre, France