2023-508643-46-00招募中2 期
Comparison of the efficacy and safety of valaciclovir in the prevention of transmission and treatment of intrauterine infection in pregnant women with primary cytomegalovirus infection depending on the used drug dose - the first Polish non-commercial non-inferiority clinical trial.
Instytut Matki I Dziecka5 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年2月26日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Percentage of newborns in whom CMV DNA was not detected in the amniotic fluid in the compared groups (assessed at visits 4 and 5).
研究概览
简要总结
The aim of the study is to compare the efficacy and safety of valacyclovir in the prevention of transmission and treatment of intrauterine infection in pregnant women with primary CMV infection in a dose-dependent manner.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Badanie noworodka po porodzie i ocena stanu Pacjentki
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women aged 18 years and older.
- •The presence of IgG antibodies to CMV, whose previous result in the current pregnancy was negative (seroconversion) and/or antibodies to CMV in the IgM and IgG classes with low avidity (below 50% or index marked by the laboratory as low avidity)
- •The presence of the above-mentioned antibodies before 16 weeks of pregnancy.
- •Giving written informed consent to participate in the study.
- •Confirmed singleton pregnancy.
排除标准
- •Pregnant women aged under
- •Known allergy or hypersensitivity to valacyclovir or acyclovir.
- •Mental disorder or intellectual disability.
- •Renal disease, abnormal liver function parameters, chronic diseases.
- •A patient who participated in any other clinical trial 3 months before enrollment in the study.
- •Positive result of screening tests for viral diseases performed routinely in accordance with the standard of perinatal care (HBV, HIV, HCV, TOXO, WR).
- •Patients not vaccinated against tuberculosis.
- •Use of any antiepileptic drugs.
- •Contraindications to magnetic resonance imaging.
结局指标
主要结局
Percentage of newborns in whom CMV DNA was not detected in the amniotic fluid in the compared groups (assessed at visits 4 and 5).
Percentage of newborns in whom CMV DNA was not detected in the amniotic fluid in the compared groups (assessed at visits 4 and 5).
次要结局
- CMV DNA replication level in fetal blood according to CMV DNA replication level in maternal blood (assessed at visit 5).
- Platelet count in the fetus depending on the dose of drug used (assessed at visit 5)
- Percentage of missed doses of a drug in the compared groups (assessed by interview at each visit, from 1 to 5).
- The percentage of newborns in whom the presence of CMV DNA in the amniotic fluid was not detected in the compared groups depending on the level of virus replication in the amniotic fluid (assessed on visits 4 and 5).
- Assessment of the frequency of adverse events in the study groups.
研究者
Klinika Położnictwa
Scientific
Instytut Matki I Dziecka
研究点 (5)
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