This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04822441
Recruitment Status : Unknown
Verified March 2021 by Centre Hospitalier Universitaire de la Réunion.
Recruitment status was:  Recruiting
First Posted : March 30, 2021
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Dengue Fever Other: data collection

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Study on the Risks of Dengue Fever for the Fetus.
Actual Study Start Date : March 19, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Study the teratogenic effects of the dengue virus on the fetus [ Time Frame: 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 :
  1. Study the maternal-fetal transmission of dengue fever during pregnancy [ Time Frame: at childbirth ]
    Amniotic fluid positive dengue PCR (Polymerase Chain Reaction) rate

  2. Study the maternal-fetal transmission of dengue fever in the peri-partum [ Time Frame: at childbirth ]
    Umbilical cord dengue positive and / or IgM (immunoglobulin M) positive PCR rate

  3. Study the materno-placental transmission of dengue fever during pregnancy and peri-partum [ Time Frame: at childbirth ]
    Placental dengue positive PCR rate

  4. Study the consequences at the placental level of dengue, in terms of anatomopathological alterations [ Time Frame: at childbirth ]
    Placental pathology abnormalities rate


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who contracted dengue fever during pregnancy
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04822441


Locations
Layout table for location information
France
CHU de la Réunion Recruiting
Saint-Pierre, France, 97448
Contact: Lucie AUZANNEAU    +262 (0) 262 35 99 49    lucie.auzanneau@chu-reunion.fr   
Principal Investigator: Marine LAFONT, PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT04822441    
Other Study ID Numbers: 2019/CHU/14
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de la Réunion:
dengue fever ; pregnancy
Additional relevant MeSH terms:
Layout table for MeSH terms
Dengue
Fever
Body Temperature Changes
Arbovirus Infections
Vector Borne Diseases
Infections
 Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral