Materno-fetal Consequences of Symptomatic Dengue in Pregnant Wowen in French Guiana
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 628
- 试验地点
- 1
- 主要终点
- Prematurity rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Prematurity rate
时间窗: 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.
次要结局
- 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)
- Rate of eclampsia(9 months maximum)
- Rate of fetal death in utero(9 months maximum)
- Spontaneous abortion rate(9 months maximum)