2022-500714-25-01招募中3 期
Congenital CMV treated with valaciclovir during pregnancy: a prospective cohort study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 112
- 试验地点
- 7
- 主要终点
- The rate of vertical transmission, assessed by CMV PCR on amniotic fluid collected during an amniocentesis at 20w. This result will be reconfirmed by PCR on a urine sample postnatally.
研究概览
简要总结
This study aims to investigate the effectivity of valaciclovir to prevent vertical CMV transmission during pregnancy in first trimester primary maternal CMV infections.
入排标准
- 年龄范围
- In utero 至 64 years（In utero, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •18 years or older
- •Proven first trimester primary CMV infection
排除标准
- •Participant has a history of kidney function problems, liver function problems, immunocomprimised
- •Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
- •Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
- •Participation in an interventional Trial with an investigational medicinal product (IMP) or device
结局指标
主要结局
The rate of vertical transmission, assessed by CMV PCR on amniotic fluid collected during an amniocentesis at 20w. This result will be reconfirmed by PCR on a urine sample postnatally.
The rate of vertical transmission, assessed by CMV PCR on amniotic fluid collected during an amniocentesis at 20w. This result will be reconfirmed by PCR on a urine sample postnatally.
次要结局
- Imaging abnormalities indicative for vertical transmission assed on ultrasound two weekly and on MRI at 30w GA.
- Maternal safety assessed by blood analysis (hematology, liver function, kidney function) and clinically
- Fetal safety assessed by ultrasound prenatally, blood analysis at birth on umbilical cord blood (hematology, liver function), postnatal urine sample, MRI postnatally
- Long term effects: hearing assessment yearly until year 4 and neurodevelopmental follow-up at 1,2 and 5 years of age.
研究者
Lennart Van der Veeken
Scientific
UZ Leuven
研究点 (7)
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