A Pilot Study for Implementation of First Trimester Screening of Aneuploidies in Campania Region
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- compliance to the screening
研究概览
简要总结
The study aims to compare two different protocols for first trimester screening of aneuploidies, one based on nuchal translucency and NIPT and another one based on the integration between combined test and NIPT, in order to identify which is the most adequate for the Campania region.
In particular, a cost-benefit comparison will be made which will take into account for each method:
- Actual costs;
- Percentage of patients who agree to undergo the proposed screening and number of patients who undergo extra tests not included in the screening protocol;
- Post-invasive procedure miscarriage rate;
- False positives (fetuses undergoing an invasive procedure for a positive screen, which have a normal karyotype).
详细描述
INTRODUCTION Aneuploidies are pathologies characterized by an alteration in the number of chromosomes. They represent the most common form of fetal abnormalities.
The prenatal diagnosis of aneuploidy is currently based both on invasive diagnostic procedures (amniocentesis and CVS) and on non-invasive screening tests.
Invasive procedures are diagnostic tests, but they are burdened by quite high costs and by a risk of miscarriage, which is estimated at around 0.5-1%. For these reasons, these procedures can not offered to all pregnant patients.
The Bindi Decree in 1988 defined advanced maternal age (>35 years) as a sufficient indication to offer an invasive procedure. However, screening based on maternal age alone demonstrated very low sensitivity (about 35%) with a very high false positive rate (about 15%). Furthermore, if we consider the progressive increase in maternal age in the first pregnancy, we realize that the number of patients who fall into the high-risk group according to maternal age is extremely high. According to Cedap data 2013, around 25% of pregnant women were aged >35; this means that invasive procedures were offered to about 1 in 4 patients.
Over the years, aneuploidy screening has improved, first thanks to the introduction of biochemical markers (tri-tests and quadruple-tests) and, then, with the revolutionary advent of combined screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •all patients referred to our hospital for first trimester screening scan
排除标准
- •maternal age<18
- •twin pregnancies
- •lack of a signed consent form
结局指标
主要结局
compliance to the screening
时间窗: up to 9 months
percentage of patients not performing test not included in arm protocol
次要结局
- spontaneous abortions(up to seven days)
- sensitivity and specificity of two protocols(up to 9 months)
- total costs(up to 3 months)
研究者
Laura Sarno
Principal Investigator, Researcher
Federico II University