Prospective Study on the Risks of Dengue Fever for the Fetus. (ERiDenF)

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.

Study Overview

• Status: Recruiting
• Conditions: Dengue Fever
• Intervention / Treatment: Other: data collection

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• France
  • Saint-Pierre, France, 97448
    • Recruiting
    • CHU de la Réunion
    • Contact: Lucie AUZANNEAU; Phone Number: +262 (0) 262 35 99 49; Email: lucie.auzanneau@chu-reunion.fr
    • Principal Investigator: Marine LAFONT, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients who contracted dengue fever during pregnancy

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Other: data collection; 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)	Other: data collection; 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)	Other: data collection; Ultrasound follow-up maternal dengue serology PCR (Polymerase Chain Reaction) and dengue serology of the umbilical cord

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study the maternal-fetal transmission of dengue fever during pregnancy	Amniotic fluid positive dengue PCR (Polymerase Chain Reaction) rate	at childbirth
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
Study the materno-placental transmission of dengue fever during pregnancy and peri-partum	Placental dengue positive PCR rate	at childbirth
Study the consequences at the placental level of dengue, in terms of anatomopathological alterations	Placental pathology abnormalities rate	at childbirth

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: dengue fever ; pregnancy
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Body Temperature Changes; Hemorrhagic Fevers, Viral; Fever; Dengue
• Other Study ID Numbers: 2019/CHU/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No