Universal Screening Program for Cytomegalovirus Infection in the First Trimester of Pregnancy: A Multicentre Pilot Study in the Area of Barcelona (CITEMB Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,357
- 试验地点
- 1
- 主要终点
- Neonatal infection rate (congenital CMV)
研究概览
简要总结
The aim of this study is to evaluate a universal cCMV screening programme in the first trimester of pregnancy in primary care in Catalonia (Spain).
详细描述
This is the pilot study of implementation of the CMV universal screening program in the first trimester of pregnancy Barcelona and its metropolitan area.
General objective The aim of this study is to evaluate a universal CMV screening programme in the first trimester of pregnancy in primary care.
Specific aims of this pilot study:
- Estimate the percentage of acceptance of CMV screening in the population
- To observe and to determine the rate of CMV primary infection in the first trimester of pregnancy
- To identify and describe the rate of the vertical fetal infection detected through the amniocentesis of the 2nd trimester
- To identify and describe the rate of fetal sequelae (due to the primary CMV infection in the first trimester), obtained by imaging techniques (ultrasound and MRI)
- To identify and describe the rate of neonatal infection (congenital CMV)
- To identify and describe the rate of sequelae for congenital CMV at one year of the child's age
- To identify and describe the percentage rate of TOP following the diagnosis of primary infection on CMV
- To identify and describe the rate of legal of TOP following the diagnosis of fetal infection
- To identify and describe the rate of TOP following the diagnosis of fetal anomalies
- To obtain and describe the annual cost of CMV screening in the first quarter in Catalonia (Spain).
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
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •maternal age 16 years or older, and
- •gestational age less than 14 weeks.
排除标准
- •language barrier preventing informed consent,
- •gestational age at blood sampling above 14 weeks, and
- •consent withdrawal
结局指标
主要结局
Neonatal infection rate (congenital CMV)
时间窗: 6-27 months
no. PCR-CMV in neonatal urine/total primary infections (IgG positive with IgM positive and low or intermediate avidity).
CMV seroprevalence in first trimester of pregnancy
时间窗: 18-19 months
Nº IgG positive with negative IgM + IgG positive with positive IgM and high avidity) / Nº of serologies performed.
Prevalence of CMV primary infection in the first trimester of pregnancy or in the periconceptional period
时间窗: 18-19 months
Nº IgG positive with IgM positive and low or intermediate avidity / Nº serologies performed.
Fetal infection rate at 2nd trimester amniocentesis
时间窗: 3-24 months
Nº positive PCR-CMV in amniotic fluid/total amniocentesis.
Rate of fetal compromise by imaging techniques (ultrasound and MRI) after first trimester / periconceptional CMV infection
时间窗: 3-24 months
ultrasound or MRI abnormalities attributable to CMV/total primary infections (IgG positive with IgM positive and low or intermediate avidity).
次要结局
- Congenital CMV sequelae rate at one year of life(18-36 months)
- Annual cost of CMV screening in the first trimester(month 19-24)
- Rate of TOP after diagnosis of primary infections:(2-19 months)
- Rate of legal termination of pregnancy after diagnosis of fetal infection(3-19 months)
- Rate of TOP after diagnosis of fetal anomalies(3-19 months)
- no. TOP after PCR-CMV in positive amniotic fluid and with fetal involvement/total primoinfections (IgG positive with IgM positive and low or intermediate avidity).(2-18 months)