Biomarkers of Fetal Infection and Disease Following Maternal HCMV Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Number of Participants With Abnormal Laboratory Values in fetal blood
研究概览
简要总结
The purposes of this study are to determine 1) if the diagnosis of CMV fetal infection could be done directly in the maternal blood instead of requesting an amniocentesis and 2) if innovative technologies such as proteomic, transcriptomic, methylomic and lipidomic applied in fetal samples could allow the discovery of new biomarkers of fetal infection.
详细描述
Human cytomegalovirus (HCMV) is the most common cause of congenital infection worldwide. The diagnosis of CMV fetal infection relies on the detection of viral DNA in amniotic fluid by polymerase chain reaction after amniocentesis. Non-invasive diagnosis of fetal infection directly in maternal blood is not available. Symptoms develop in about 10% of HCMV-infected fetuses. Despite important advance in medical imaging, establishing the prognosis of an infected fetus remains challenging. Thrombocytopenia, blood HCMV DNA, anti-HCMV immunoglobulin M and β2-microglobulin are recognized biomarkers of symptomatic fetal infections. However, the predictive value of these individual markers is not. Omics technologies could help to establish multimarker signatures of symptomatic infections.
The objective of the study is to:
- validate fetal blood HCMV DNA, anti-HCMV immunoglobulin M , β2-microglobulin and platelet count as biomarkers of fetal disease;
- identify new biomarkers of severe fetal disease using transcriptomic, methylomic and lipidomic analyses of fetal blood and of amniotic fluid.
- validate a non-invasive CMV fetal infection diagnosis tool based on deep-sequencing of targeted CMV genes in maternal blood
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Informed consent obtained from the mother;
- •Pregnant women either with a history of primary CMV infection in pregnancy or carrying a fetus with ultrasound features compatible with CMV infection and willing to have amniocentesis for fetal diagnosis of CMV infection
- •Control cases :
- •Pregnant women carrying a fetus with aneuploidy-dysgonosomy
排除标准
- •Fetuses older than the 26 weeks of gestation at the time of diagnosis of HCMV infection or impossibility to collect foetal samples by the end of the 26th week of gestation
- •Mother unable to understand the protocol
- •Absence of informed consent
- •Any clinical rationale not to perform cordocentesis
- •Mother <18 years age
- •Administration of immunoglobulins or anti-viral therapy to the mother before the collection of fetal samples or before the diagnosis of symptomatic fetal infection
- •Administration of anti-HCMV drugs to the foetus before the collection of fetal samples or before the diagnosis of symptomatic fetal infection
- •Administration of immunosuppressive drugs to the mother during pregnancy
- •Maternal auto immune disorders
- •Multiple pregnancies.
- •Control cases :
- •Mother unable to understand the protocol
- •Absence of informed consent
结局指标
主要结局
Number of Participants With Abnormal Laboratory Values in fetal blood
时间窗: At 23 weeks gestation +/- 3 weeks
Fetal platelet in mm3/ml, β2 microglobulinein mg/L, proteins concentration in mg/L , Metabolites concentration in mmoles/l , Lipids concentration in mmoles/l , RNA messagers concentration in µg/ml profil
次要结局
- Number of Participants With Abnormal Laboratory Values in amniotic fluid(At 23 weeks gestation +/- 3 weeks)
- Non invasive diagnosis of fetal CMV infection in maternal blood in UI/mL.(At 23 weeks gestation +/- 5 weeks)