CTIS2023-508643-46-00招募中1 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. - POL PRENATAL CMV
Instytut Matki I Dziecka0 个研究点目标入组 200 人开始时间: 2023年10月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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)., Antibodies to CMV in the IgM and IgG classes with 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 18., 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.
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