Materno-fetal Consequences of Symptomatic Dengue in Pregnant Wowen in French Guiana

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

COMPLETED

Total Enrollment

628 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-11

Study Completion Date

2015-07-11

Brief Summary

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Symptomatic dengue virus infection in pregnant women could affect the mother, fetus and the newborn at birth. The risks of postpartum hemorrhage, prematurity and low birth weight are increased in dengue fever. Cases of vertical transmission have been described. This study therefore proposes to quantify these risks in a pregnant woman presenting a clinical picture of dengue fever through a prospective, longitudinal and comparative study.

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Detailed Description

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The main objective of the study is to compare the occurrence of prematurity between women who presented with symptomatic dengue fever and those who did not. However, febrile syndrome is known to be one of the main major risk factors for prematurity whatever its etiology (National College of French Gynecologists and Obstetricians CNGOF, High Authority of Health HAS). Dividing the unexposed group into 2 groups (group without fever or dengue GNES and group with fever not due to the dengue virus GNEF) is a means of observing on the one hand the effects of symptomatic dengue (the combination of effect of fever and the effect of the dengue virus) on the primary endpoint and on the other hand to observe the effects of fever in the context of another infectious pathology on the primary endpoint. This split also makes it easy to control the number of patient enrollments in each unexposed group.

This study protocol is only interested in investigating the impact of symptomatic dengue fever in pregnant women.

Primary objective: Compare the prematurity rate of the woman with symptomatic dengue fever (exposed group: GE) during her pregnancy compared to the woman who had neither fever nor infection with the dengue virus during her pregnancy (unexposed group without fever: GNES).

Secondary objectives:

* Describe the clinical pictures of symptomatic dengue fever in pregnant women;
* Compare the proportion of rates of prematurity, threat of premature delivery, spontaneous miscarriage, pre-eclampsia, eclampsia and delivery haemorrhage between the GE / GNES group and between the GE / GNEF group ( pregnant women who presented with dengue GE, those who had neither fever nor dengue during their pregnancy GNES and those who presented a fever not due to the dengue virus GNEF);
* Compare the proportion of MFIU and hypotrophy of newborns born to mothers between the GE / GNES group and between the GE / GNEF group;
* Describe the clinical and biological pictures of newborns at birth of mothers who presented with symptomatic dengue fever during their pregnancy (GE)
* Describe the morphological, biometric and velocimetric abnormalities of obstetric doppler ultrasounds of pregnant women who presented with dengue fever during their pregnancy (GE).
* Check for the presence of the dengue virus in the placenta of pregnant women who have had dengue fever during their pregnancy (GE).
* Constitute a direct biological collection (serums, placentas) used for the research of the dengue virus.

Epidemiological, etiological exposed-unexposed, multicentric, dynamic and contemporary with biological collection

Conditions

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Dengue Pregnancy Preterm Women Fever Parturition; Precipitate Infant, Newborn

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Exposed group (GE)

Pregnant women with symptomatic dengue fever, confirmed biologically between the presumed date of conception and the date of delivery.

Biological sampling and collection (serum)

Intervention Type OTHER

Detection of the dengue virus during the next scheduled biological assessment as part of normal pregnancy monitoring (additional tube of blood) among women from GNES and GNEF groups

Biological sampling and collection (placenta)

Intervention Type OTHER

Detection of dengue virus in the placenta of GE patients (additional tube of placenta)

Questionnaire

Intervention Type OTHER

Questionnaire on the patient's socio-economic conditions (10-minute interview with the Clinical Research Associate, CRA).

Data collection

Intervention Type OTHER

Case Report Form will be completed by a Clinical Research Associate (CRA) from the medical file of the patient concerned and of her child at the 3 visits carried out (Pre inclusion V0 or Inclusion V1, Childbirth V2 and Maternity leave V3).

Unexposed group with fever (GNEF)

Pregnant women presenting a febrile syndrome not due to the dengue virus between the presumed date of conception and the date of delivery, excluding malaria, rubella, toxoplasmosis, chickenpox, listeriosis, CMV infection and primary HIV infection.

Biological sampling and collection (serum)

Intervention Type OTHER

Detection of the dengue virus during the next scheduled biological assessment as part of normal pregnancy monitoring (additional tube of blood) among women from GNES and GNEF groups

Questionnaire

Intervention Type OTHER

Questionnaire on the patient's socio-economic conditions (10-minute interview with the Clinical Research Associate, CRA).

Data collection

Intervention Type OTHER

Case Report Form will be completed by a Clinical Research Associate (CRA) from the medical file of the patient concerned and of her child at the 3 visits carried out (Pre inclusion V0 or Inclusion V1, Childbirth V2 and Maternity leave V3).

Unexposed group without fever or dengue (GNES)

Pregnant women exhibiting neither febrile syndrome nor asymptomatic dengue fever between the presumed date of conception and the date of delivery.

Biological sampling and collection (serum)

Intervention Type OTHER

Detection of the dengue virus during the next scheduled biological assessment as part of normal pregnancy monitoring (additional tube of blood) among women from GNES and GNEF groups

Questionnaire

Intervention Type OTHER

Questionnaire on the patient's socio-economic conditions (10-minute interview with the Clinical Research Associate, CRA).

Data collection

Intervention Type OTHER

Case Report Form will be completed by a Clinical Research Associate (CRA) from the medical file of the patient concerned and of her child at the 3 visits carried out (Pre inclusion V0 or Inclusion V1, Childbirth V2 and Maternity leave V3).

Interventions

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Biological sampling and collection (serum)

Detection of the dengue virus during the next scheduled biological assessment as part of normal pregnancy monitoring (additional tube of blood) among women from GNES and GNEF groups

Intervention Type OTHER

Biological sampling and collection (placenta)

Detection of dengue virus in the placenta of GE patients (additional tube of placenta)

Intervention Type OTHER

Questionnaire

Questionnaire on the patient's socio-economic conditions (10-minute interview with the Clinical Research Associate, CRA).

Intervention Type OTHER

Data collection

Case Report Form will be completed by a Clinical Research Associate (CRA) from the medical file of the patient concerned and of her child at the 3 visits carried out (Pre inclusion V0 or Inclusion V1, Childbirth V2 and Maternity leave V3).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* presenting a symptomatic dengue fever, confirmed biologically between the presumed date of conception (date determined after the first trimester dating ultrasound) and the date of delivery.

* not presenting biologically confirmed dengue fever;
* with asymptomatic dengue fever between the presumed date of conception and the date of delivery.

* Unexposed group with fever (GNEF)

* presenting an infectious syndrome not due to the dengue virus between the presumed date of conception (date determined after the ultrasound dating of the first trimester) and the date of delivery.

* presenting with an infectious syndrome in the context of rubella (before 18 weeks), chickenpox, malaria, listeriosis, toxoplasmosis, primary HIV infection and CMV infection.

* Having neither fever (above 38.5 ° C for more than 48 hours) nor dengue confirmed biologically (symptomatic or not) since the beginning of pregnancy.

* Having presented a febrile syndrome (fever above 38.5 ° C for more than 48 hours) or dengue fever confirmed biologically (symptomatic or not) since the beginning of pregnancy.

Exclusion Criteria

* Person included in the study with biologically confirmed dengue fever (symptomatic or not) between the date of inclusion and the date of delivery.

* Unexposed group without fever or dengue (GNES)

People included in the study,

* with biologically confirmed dengue fever (symptomatic or not) between the date of inclusion and the date of delivery;
* having presented a febrile syndrome (fever above 38.5 ° C for more than 48 hours) between inclusion and childbirth.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes