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

Fever Clinical Trial

— CMFdeng  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04989673
• Other study ID #: CMFdeng
• Status: Completed
• Start date: July 11, 2012
• Est. completion date: July 11, 2015

Study information

• Verified date: July 2021
• Source: Centre Hospitalier de Cayenne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: July 11, 2015
• Est. primary completion date: February 12, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

• 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.

Related Conditions & MeSH terms

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

Intervention

Other:
• 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
• Biological sampling and collection (placenta)
Detection of dengue virus in the placenta of GE patients (additional tube of placenta)
• Questionnaire
Questionnaire on the patient's socio-economic conditions (10-minute interview with the Clinical Research Associate, CRA).
• 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).

Locations

Country	Name	City	State
French Guiana	General Hospital of Cayenne	Cayenne

Sponsors (6)

Lead Sponsor	Collaborator
Centre Hospitalier de Cayenne	Centre Hospitalier de Kourou, Centre Hospitalier de l'Ouest Guyanais, Centres de Protection Maternelle Infantile Cayenne, Kourou et Saint-Laurent du Maroni, Private midwife Cayenne, Kourou et Saint-Laurent du Maroni, Private physicians Cayenne, Kourou et Saint-Laurent du Maroni

Country where clinical trial is conducted

French Guiana, 

References & 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. — View Citation

Basurko C, Everhard S, Matheus S, Restrepo M, Hildéral 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 — View Citation

Basurko C, Matheus S, Hildéral 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):18 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Threatened Premature Delivery (PAD) rate in each group	The threat of premature delivery is a pathology associating cervical changes and regular and painful uterine contractions occurring between 22 and 36 weeks of amenorrhea + 6 days (HAS).; Cervical changes will be assessed by endovaginal ultrasound of the cervix on at least 1 of the following criteria: neck length less than or equal to 25mm; funnel opening or expansion of the internal orifice of the neck; protrusion of amniotic membranes in the cervix.; The close and regular frequency of uterine contractions (generalized and intermittent hardening of the uterus lasting 30 to 60 seconds) will be objectified by a tocographic recording: at least 3 contractions in 30 minutes. The pain will be assessed by the patient with the possible help of the visual analogue scale (VAS> = 5).	9 months maximum
Secondary	Fetal hypotrophy rate	Fetal hypotrophy corresponds to a biometry below the 10th percentile according to the growth curve of the French College of Fetal Ultrasound (CFEF).; The diagnosis is based on the measurement during an obstetric ultrasound of the biparietal diameter, head circumference (PC), abdominal diameter, abdominal perimeter (PA) and femoral length (FL).; The fetal weight is estimated according to the Hadlock formula [46] log10 EPF = 1.326 + 0.0107 PC + 0.0438 PA + 0.158 LF - 0.00326 (PA x LF).	9 months maximum
Secondary	Low birth weight	The low birth weight corresponds to a birth weight below the 10th percentile for the term on the CFEF curve.; The weight will be measured within half an hour after giving birth.	9 months maximum
Secondary	Postpartum hemorrhage rate	corresponds to a loss of blood of more than 500 ml within 24 hours between birth and leaving the maternity hospital.; This criterion will be measured by midwives or nurses in the operating room (double collection bag: one for amniotic fluid and the other for blood loss). In postpartum, the loss is estimated daily by the midwives or the physician.	9 months maximum
Secondary	Rate of preeclampsia	Pre-eclampsia is de novo hypertension (SBP> = 140 mmHg or ADP> 90 mmHg) in the second part of pregnancy, with the onset of proteinuria greater than 300 mg / 24h or onset of proteinuria in a woman with chronic hypertension. The hypertension will be objectified on at least two blood pressure measurements in a patient lying down and calm for at least 5 minutes or on a blood pressure holter over 24 hours with a cuff adapted to the body of the patient. Chronic hypertension corresponds to a patient on antihypertensive medication. Proteinuria is defined as the pathological elimination in the urine of a quantity of protein greater than 80 mg / day. The 24-hour urine collection for proteinuria can be done in a hospital setting or on an outpatient basis.	9 months maximum
Secondary	Rate of eclampsia	Eclampsia is defined as the occurrence of seizures, either in the 2nd part of pregnancy, or during childbirth, or in the first 48 hours postpartum, in a woman with preeclampsia.; The occurrence of convulsions in the patient must be validated by a physician or a midwife.	9 months maximum
Secondary	Rate of fetal death in utero	Fetal death from 22 weeks of amenorrhea. Death will be confirmed by the absence of cardiac activity on obstetric Doppler ultrasound.	9 months maximum
Secondary	Spontaneous abortion rate	Early: before 16 SA Late: between 16 and 22 SA. The death of the fetus will be confirmed by examination by the physician or midwife. It should be verified that this is not a voluntary abortion or that he has had medication or a triggering event.	9 months maximum