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Clinical Trials/NCT04826081
NCT04826081
Unknown
Not Applicable

Prospective Study on the Risks of Symptomatic Dengue on Pregnancy

Centre Hospitalier Universitaire de la Réunion1 site in 1 country336 target enrollmentJune 15, 2021
ConditionsDenguePregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dengue
Sponsor
Centre Hospitalier Universitaire de la Réunion
Enrollment
336
Locations
1
Primary Endpoint
Evaluate the difference in the proportion of intrauterine growth retardation (IUGR) between the Case group and the Control group
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2021
End Date
March 2024
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: at childbirth

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

Secondary Outcomes

  • 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 small weight for gestational age between the case group and the control group between the case group and the control group(at childbirth)
  • 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 bleeding from delivery between the case group and the control group between the case group and the control group(at childbirth)

Study Sites (1)

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