Clinical trial NCT04989673: Materno-fetal Consequences of Symptomatic Dengue in Pregnant Wowen in French Guiana
Official title: Materno-fetal Consequences of Symptomatic Dengue in Pregnant Wowen in French Guiana
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dengue
Pregnancy Preterm
Women
Fever
Parturition; Precipitate
Infant, Newborn
Keywords: Symptomatic Dengue
Pregnancy Preterm
Vertical transmission
Fetus
French Guiana
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier de Kourou
name: Centre Hospitalier de l'Ouest Guyanais
name: Centres de Protection Maternelle Infantile Cayenne, Kourou et Saint-Laurent du Maroni
name: Private physicians Cayenne, Kourou et Saint-Laurent du Maroni
name: Private midwife Cayenne, Kourou et Saint-Laurent du Maroni
First posted: 2021-08-04
Enrollment: 628
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: 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.

Detailed description: 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

Eligibility criteria: \* Exposed group (GE)

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.

Non inclusion Criteria:

* 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)

Inclusion Criteria:

* 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.

Non inclusion Criteria:

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

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)

Inclusion Criteria:

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

Non inclusion criteria:

* 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:

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.

Primary outcomes:
measure: Prematurity rate
timeFrame: 9 months maximum
Secondary outcomes:
measure: Threatened Premature Delivery (PAD) rate in each group
timeFrame: 9 months maximum
measure: Fetal hypotrophy rate
timeFrame: 9 months maximum
measure: Low birth weight
timeFrame: 9 months maximum
measure: Postpartum hemorrhage rate
timeFrame: 9 months maximum
measure: Rate of preeclampsia
timeFrame: 9 months maximum
measure: Rate of eclampsia
timeFrame: 9 months maximum
measure: Rate of fetal death in utero
timeFrame: 9 months maximum
measure: Spontaneous abortion rate
timeFrame: 9 months maximum
Other outcomes:
Locations:
city: Cayenne
country: French Guiana
facility: General Hospital of Cayenne
Study officials:
affiliation: Centre Hospitalier de Saint-Laurent du Maroni
name: Gabriel CARLES
role: PRINCIPAL_INVESTIGATOR
References:
citation: Basurko C, Carles G, Youssef M, Guindi WE. Maternal and fetal consequences of dengue fever during pregnancy. Eur J Obstet Gynecol Reprod Biol. 2009 Nov;147(1):29-32. doi: 10.1016/j.ejogrb.2009.06.028. Epub 2009 Jul 24.
citation: Carles G, Peiffer H, Talarmin A. Effects of dengue fever during pregnancy in French Guiana. Clin Infect Dis. 1999 Mar;28(3):637-40. doi: 10.1086/515144.
citation: Carles G, Talarmin A, Peneau C, Bertsch M. [Dengue fever and pregnancy. A study of 38 cases in french Guiana]. J Gynecol Obstet Biol Reprod (Paris). 2000 Dec;29(8):758-762. French.
citation: Basurko C, Everhard S, Matheus S, Restrepo M, Hilderal H, Lambert V, Boukhari R, Duvernois JP, Favre A, Valmy L, Nacher M, Carles G. A prospective matched study on symptomatic dengue in pregnancy. PLoS One. 2018 Oct 3;13(10):e0202005. doi: 10.1371/journal.pone.0202005. eCollection 2018.
citation: Basurko C, Matheus S, Hilderal H, Everhard S, Restrepo M, Cuadro-Alvarez E, Lambert V, Boukhari R, Duvernois JP, Favre A, Nacher M, Carles G. Estimating the Risk of Vertical Transmission of Dengue: A Prospective Study. Am J Trop Med Hyg. 2018 Jun;98(6):1826-1832. doi: 10.4269/ajtmh.16-0794. Epub 2018 Apr 19.