General Hospital of Cayenne
Cayenne, 97306, French Guiana
NCT Number: NCT04989673
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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Observational
Cayenne, 97306, French Guiana
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:
Epidemiological, etiological exposed-unexposed, multicentric, dynamic and contemporary with biological collection
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non inclusion Criteria:
Inclusion criteria
Non inclusion Criteria:
Exclusion criteria
Inclusion criteria
Non inclusion criteria:
Exclusion criteria
People included in the study,
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
Detection of dengue virus in the placenta of GE patients (additional tube of placenta)
Questionnaire on the patient's socio-economic conditions (10-minute interview with the Clinical Research Associate, CRA).
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).
Time frame: 9 months maximum
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.
Time frame: 9 months maximum
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:
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).
Time frame: 9 months maximum
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).
Time frame: 9 months maximum
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.
Time frame: 9 months maximum
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.
Time frame: 9 months maximum
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.
Time frame: 9 months maximum
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.
Time frame: 9 months maximum
Fetal death from 22 weeks of amenorrhea. Death will be confirmed by the absence of cardiac activity on obstetric Doppler ultrasound.
Time frame: 9 months maximum
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.
Centre Hospitalier de Cayenne
Other
Acronym: CMFdeng
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