Prospective Study on the Risks of Dengue Fever for the Fetus.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Study the teratogenic effects of the dengue virus on the fetus
研究概览
简要总结
Dengue is the most common arbovirus worldwide (390 million people infected each year) and belongs to the Flavivirus genus of the Flaviviridae family like Zika. Its expansion has been rapid since the last decade with an increase in the number of cases of 400% and the first cases of indigenous dengue described in Europe.
Current data on the consequences of dengue fever on the fetus are incomplete. The risk of maternal-fetal transmission of dengue during the peripartum period has now been recorded in numerous case reports and a few case series for patients who contracted dengue in the 12 days preceding childbirth or at the time of delivery. However, the transmission of dengue is highly variable depending on the studies ranging from 1.6 to 15% and the consequences for the newborn are very variable ranging from simple thrombocytopenia to death in severe neonatal dengue.
Regarding the risk of malformation, a few old cases of heart disease, hydrocephalus and neural tube closure abnormalities have been described in the literature following exposure to dengue fever during pregnancy. Since no malformative case has been described, however, to our knowledge, no prospective study with specialized ultrasound monitoring has been performed for pregnant women who contracted dengue during their pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patients
- •Affiliated with social security
- •Symptomatic or pauci-symptomatic dengue
- •Biological confirmation of dengue fever by dengue positive PCR or IgM positive during the current dengue episode
排除标准
- •Multiple pregnancy
- •Patient's refusal
- •Protected persons: person deprived of liberty by judicial or administrative decision, minor, and person subject to a legal protection measure: guardianship or curators)
结局指标
主要结局
Study the teratogenic effects of the dengue virus on the fetus
时间窗: at childbirth
Rate of fetal anomalies such as infectious fetal disease or any other fetal anomaly detected during specialized antenatal ultrasound follow-up.
次要结局
- Study the maternal-fetal transmission of dengue fever during pregnancy(at childbirth)
- Study the materno-placental transmission of dengue fever during pregnancy and peri-partum(at childbirth)
- Study the maternal-fetal transmission of dengue fever in the peri-partum(at childbirth)
- Study the consequences at the placental level of dengue, in terms of anatomopathological alterations(at childbirth)