Clinical trial NCT04826081: Study on the Risks of Symptomatic Dengue on Pregnancy
Official title: Prospective Study on the Risks of Symptomatic Dengue on Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dengue
Pregnancy
Keywords: dengue fever ; pregnancy
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 336
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Case : Patients who contracted dengue fever during pregnancy Control : Patient who does not get dengue fever during pregnancy

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.


Eligibility criteria: Inclusion Criteria for the case :

* Pregnant patients
* Major
* Affiliated with social security
* Symptomatic or pauci-symptomatic dengue
* Biological confirmation of dengue fever

Inclusion Criteria for the control :

* Pregnant patients
* Major
* Affiliated with social security
* Asymptomatic

Exclusion Criteria for the 2 group :

* 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)

Primary outcomes:
measure: Evaluate the difference in the proportion of intrauterine growth retardation (IUGR) between the Case group and the Control group
timeFrame: at childbirth
Secondary outcomes:
measure: Evaluate the difference in the proportion of prematurity between the case group and the control group
timeFrame: at childbirth
measure: Evaluate the difference in the proportion of late miscarriage between the case group and the control group
timeFrame: at childbirth
measure: Evaluate the difference in the proportion of fetal death in utero between the case group and the control group
timeFrame: at childbirth
measure: Evaluate the difference in the proportion of preeclampsia between the case group and the control group
timeFrame: at childbirth
measure: 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
timeFrame: at childbirth
measure: 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
timeFrame: at childbirth
Other outcomes:
Locations:
city: Saint-Pierre
country: France
facility: CHU de la Réunion
Study officials:
References: