NCT04826081

Brief Summary

Dengue fever is the most common arbovirus worldwide (390 million people infected per year) and is a global public health problem. This public health problem is also becoming European due to its rapid expansion over the past decade with an increase in cases of 400% and the appearance of the first indigenous cases of dengue in Europe. Studies on the consequences of dengue fever on pregnancy find contradictory results. In fact, most of these studies are observational studies describing the risk of dengue fever for pregnancy, without comparison with a control group or comparing the different pregnancy morbidities to those found during pregnancy in the general population. Other research is retrospective case-control studies with major biases in the definitions of obstetric complications, which makes the results questionable. The study therefore proposes to carry out a prospective case-control study with rigorous matching criteria, strict definitions of cases, controls and obstetric complications.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
336

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

November 4, 2021

Status Verified

November 1, 2021

Enrollment Period

2.5 years

First QC Date

March 30, 2021

Last Update Submit

November 3, 2021

Conditions

DenguePregnancy

Keywords

dengue fever ; pregnancy

Outcome Measures

Primary Outcomes (1)

  • Evaluate the difference in the proportion of intrauterine growth retardation (IUGR) between the Case group and the Control group

    Birth weight \<3rd percentile according to Sentinel Network Perinatal Database : AUDIPOG

    at childbirth

Secondary Outcomes (6)

  • Evaluate the difference in the proportion of prematurity between the case group and the control group

    at childbirth

  • Evaluate the difference in the proportion of late miscarriage between the case group and the control group

    at childbirth

  • Evaluate the difference in the proportion of fetal death in utero between the case group and the control group

    at childbirth

  • Evaluate the difference in the proportion of preeclampsia between the case group and the control group

    at childbirth

  • Evaluate the difference in the proportion of bleeding from delivery between the case group and the control group between the case group and the control group

    at childbirth

  • +1 more secondary outcomes

Study Arms (2)

Case

women who contracted symptomatic dengue fever during pregnancy

Other: data collection

Control

women who did not contract symptomatic dengue fever during pregnancy

Other: data collection

Interventions

data collectionOTHER

data collection

CaseControl

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Case : Patients who contracted dengue fever during pregnancy Control : Patient who does not get 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
  • Pregnant patients
  • Major
  • Affiliated with social security
  • Asymptomatic

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de la Réunion

Saint-Pierre, 97448, France

RECRUITING

MeSH Terms

Conditions

Dengue

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Lucie AUZANNEAU

CONTACT

0262359949lucie.auzanneau@chu-reunion.fr

Study Design

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

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 1, 2021

Study Start

June 15, 2021

Primary Completion

January 1, 2024

Study Completion

March 1, 2024

Last Updated

November 4, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)