Study on the Risks of Symptomatic Dengue on Pregnancy

• Conditions: Dengue; Pregnancy
• Interventions: Other: data collection

• Registration Number: NCT04826081
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-01
• Study Start: 2021-06-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-04
• Primary Completion: 2024-01
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 336

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	data collection	women who contracted symptomatic dengue fever during pregnancy
Control	data collection	women who did not contract symptomatic dengue fever during pregnancy

Primary Outcome Measures

Name	Time	Method
Evaluate the difference in the proportion of intrauterine growth retardation (IUGR) between the Case group and the Control group	at childbirth	Birth weight \<3rd percentile according to Sentinel Network Perinatal Database : AUDIPOG

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de la Réunion; 🇫🇷 Saint-Pierre, France