Study on the Risks of Symptomatic Dengue on Pregnancy (ERiDenG)

Prospective Study on the Risks of Symptomatic Dengue on Pregnancy

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Dengue
• Intervention / Treatment: Other: data collection

• Study Type: Observational
• Enrollment (Anticipated): 336

Contacts and Locations

Study Locations

• France
  • Saint-Pierre, France, 97448
    • Recruiting
    • CHU de la Réunion
    • Principal Investigator: Marine LAFONT, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case; women who contracted symptomatic dengue fever during pregnancy	Other: data collection; data collection
Control; women who did not contract symptomatic dengue fever during pregnancy	Other: data collection; data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the difference in the proportion of prematurity between the case group and the control group	Prematurity: birth between 22 and 37 weeks of amenorrhea	at childbirth
Evaluate the difference in the proportion of late miscarriage between the case group and the control group	late miscarriage: Birth between 14 and 22 weeks of amenorrhea	at childbirth
Evaluate the difference in the proportion of fetal death in utero between the case group and the control group	fetal death in utero : Negative cardiac activity in utero between 14 weeks and before childbirth	at childbirth
Evaluate the difference in the proportion of preeclampsia between the case group and the control group	preeclampsia: Arterial hypertension> 140 and / or 90 mmHg and proteinuria / 24h> 0.3g / 24h	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	bleeding from delivery: Blood loss> 500 mL in immediate postpartum up to 2 hours postpartum	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	Birth weight <10th percentile according to Sentinel Network Perinatal Database : AUDIPOG	at childbirth

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: dengue fever ; pregnancy
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Dengue
• Other Study ID Numbers: 2020/CHU/41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No