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Study on the Risks of Symptomatic Dengue on Pregnancy

NCT ID: NCT04826081

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

336 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-15

Study Completion Date

2024-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dengue Pregnancy

Keywords

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dengue fever ; pregnancy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Case

women who contracted symptomatic dengue fever during pregnancy

data collection

Intervention Type OTHER

data collection

Control

women who did not contract symptomatic dengue fever during pregnancy

data collection

Intervention Type OTHER

data collection

Interventions

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data collection

data collection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de la Réunion

Saint-Pierre, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lucie AUZANNEAU

Role: CONTACT

Phone: 0262359949

Email: [email protected]

Facility Contacts

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Lucie AUZANNEAU

Role: primary

Other Identifiers

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2020/CHU/41

Identifier Type: -

Identifier Source: org_study_id