Study on the Risks of Symptomatic Dengue on Pregnancy

Pregnancy Clinical Trial

— ERiDenG  

Official title:

Prospective Study on the Risks of Symptomatic Dengue on Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04826081
• Other study ID #: 2020/CHU/41
• Status: Recruiting
• Start date: June 15, 2021
• Est. completion date: March 2024

Study information

• Verified date: November 2021
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Lucie AUZANNEAU
• Phone: 0262359949
• Email: lucie.auzanneau[@]chu-reunion.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dengue
• Pregnancy

Intervention

Other:
• data collection
data collection

Locations

Country	Name	City	State
France	CHU de la Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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