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

NCT04822441 | Unknown

• 1 other identifier: 2019/CHU/14
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Study the maternal-fetal transmission of dengue fever during pregnancy

  at childbirth

• Study the maternal-fetal transmission of dengue fever in the peri-partum

  at childbirth

• Study the materno-placental transmission of dengue fever during pregnancy and peri-partum

  at childbirth

• Study the consequences at the placental level of dengue, in terms of anatomopathological alterations

  at childbirth

Study Arms (3)

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

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

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

Interventions

data collection 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 dengue fever before 34 weeks of amenorrhea; Patients who have contracted dengue during the peripartum period

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who contracted dengue fever during pregnancy

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

CHU de la Réunion

Saint-Pierre, 97448, France

RECRUITING

MeSH Terms

Conditions

Dengue

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: March 19, 2021
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2023
• Last Updated: November 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)