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

NCT ID: NCT04822441

Last Updated: 2021-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-19
• Study Completion Date: 2023-03-31

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.

Conditions

Dengue Fever

Keywords

dengue fever ; pregnancy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients who contracted dengue fever before 34 weeks of amenorrhea

Patients who contracted biologically proven dengue fever during pregnancy before 34 weeks outside the peri-partum period (more than 12 days before childbirth)

data collection

Intervention Type: OTHER

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

Patients who contracted dengue fever after 34 weeks of amenorrhea

Patients who contracted biologically proven dengue fever during pregnancy after 34 weeks outside the peri-partum period (more than 12 days before childbirth)

data collection

Intervention Type: OTHER

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

Patients who have contracted dengue during the peripartum period

Patients who have contracted dengue during the peripartum period or who have a suspicion of dengue (in the 12 days preceding childbirth)

data collection

Intervention Type: OTHER

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

Interventions

data collection

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de la Réunion

Saint-Pierre, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Lucie AUZANNEAU

Role: primary

Other Identifiers

2019/CHU/14

Identifier Type: -

Identifier Source: org_study_id