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

NCT04989673 | Completed DMC

• 1 other identifier: CMFdeng
• Study Type: observational
• Target: 628
• Locations: 1 country
• Sites: 1

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.

Conditions

Dengue; Pregnancy Preterm; Women; Fever; Parturition; Precipitate; Infant, Newborn

Keywords

Symptomatic Dengue; Pregnancy Preterm; Vertical transmission; Fetus; French Guiana

Outcome Measures

Primary Outcomes (1)

• Prematurity rate

  The prematurity rate of each group will be assessed according to the WHO definition: a preterm birth is a birth occurring before the 37th week of amenorrhea and after the 22nd week of amenorrhea of a living fetus of at least equal weight at 500 g. This judgment criterion will be measured by the physician or midwife in charge of the patient, and reported on the RIG and the delivery book of the service. The date of delivery will be determined based on the 1st trimester dating ultrasound. The newborn will be examined by the midwife or pediatrician on the ward and weighed within half an hour after birth. A distinction will be made between medically induced premature delivery (reasons given) and spontaneous.

  9 months maximum

Secondary Outcomes (8)

• Threatened Premature Delivery (PAD) rate in each group

  9 months maximum

• Fetal hypotrophy rate

  9 months maximum

• Low birth weight

  9 months maximum

• Postpartum hemorrhage rate

  9 months maximum

• Rate of preeclampsia

  9 months maximum

Study Arms (3)

Exposed group (GE)

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

Other: Biological sampling and collection (serum); Other: Biological sampling and collection (placenta); Other: Questionnaire; Other: Data collection

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.

Other: Biological sampling and collection (serum); Other: Questionnaire; Other: Data collection

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.

Other: Biological sampling and collection (serum); Other: Questionnaire; Other: Data collection

Interventions

Biological sampling and collection (serum) 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

Exposed group (GE); Unexposed group with fever (GNEF); Unexposed group without fever or dengue (GNES)

Biological sampling and collection (placenta) OTHER

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

Exposed group (GE)

Questionnaire OTHER

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

Exposed group (GE); Unexposed group with fever (GNEF); Unexposed group without fever or dengue (GNES)

Data collection 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).

Exposed group (GE); Unexposed group with fever (GNEF); Unexposed group without fever or dengue (GNES)

Eligibility Criteria

• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

You may qualify if:

• 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.

You may not qualify if:

• Unexposed group without fever or dengue (GNES)
• 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.
• People included in the study,

Sponsors & Collaborators

• Centre Hospitalier de Cayenne: lead
• Centre Hospitalier de Kourou: collaborator
• Centre Hospitalier de l'Ouest Guyanais: collaborator
• Centres de Protection Maternelle Infantile Cayenne, Kourou et Saint-Laurent du Maroni: collaborator
• Private physicians Cayenne, Kourou et Saint-Laurent du Maroni: collaborator
• Private midwife Cayenne, Kourou et Saint-Laurent du Maroni: collaborator

Study Sites (1)

General Hospital of Cayenne

Cayenne, 97306, French Guiana

Location

Related Publications (5)

• 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.

  PMID: 19632027 BACKGROUND

• 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.

  PMID: 10194092 BACKGROUND

• 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.

  PMID: 11139712 BACKGROUND

• 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.

  PMID: 30281605 RESULT

• 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.

  PMID: 29692297 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tubes of venous blood and or placenta sampling

MeSH Terms

Conditions

Dengue; Fever

Interventions

Surveys and Questionnaires; Data Collection

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gabriel CARLES

  Centre Hospitalier de Saint-Laurent du Maroni

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 4, 2021
• Study Start: July 11, 2012
• Primary Completion: February 12, 2015
• Study Completion: July 11, 2015
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)