NCT03200041已完成不适用
Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies
Premaitha Health2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2016年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Number of IONA test results which are concordant or discordant with Invasive test or Birth outcome.
研究概览
简要总结
The purpose of this study is to evaluate the performance of the IONA® test which is a non-invasive prenatal test (NIPT) for Down's syndrome and other chromosomal abnormalities in twin pregnancies, from a maternal blood sample.
详细描述
350 low risk and 150 high risk women with twin pregnancies will be recruited to produce a large cohort evaluation the use of the IONA test in twin pregnancies for Downs, Edwards and Patau syndrome. Reserve samples will also be used to further develop the test for other chromosomal abnormalities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Currently pregnant with twin foetuses at time of entry to study
- •Have had or are about to have a conventional screening test (combined/quad test, ultrasound scan or other NIPT)
- •If identified as high risk, intend to undergo prenatal invasive diagnosis and/or undergoing invasive prenatal therapy such as laser treatment for TTTS where a sample of amniotic fluid is taken for karyotyping.
排除标准
- •Participant herself has down syndrome or other chromosomal abnormality
结局指标
主要结局
Number of IONA test results which are concordant or discordant with Invasive test or Birth outcome.
时间窗: 18 months
IONA test results will be compared to Karyotyping from birth outcome and invasive procedures.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
Ensayo Clinico para la evaluación no invasiva de la actividad lactasa intesttinal in vivo, mediante la administracción oral de 4-Galactosil-xilosa en sujetos con clinica sugerente de intolerancia a la lactosa”Diagnostico no invasivo de la deficiencia de lactasa intestinalEUCTR2006-002793-21-ESactest S.L.
进行中（未招募）
3 期
A patient study to determine the effectiveness of a needle-free test for the diagnosis of adrenal insufficiencyAdrenal insufficiencyNutritional, Metabolic, EndocrineISRCTN26461337Sheffield Children's NHS Foundation Trust32
已完成
不适用
The development of a clinical test to assess the inflammatory phenotype of asthmabronchial hyperreactivityinflammatory lung disease10024967AsthmaNL-OMON38417niversitair Medisch Centrum Utrecht115
已完成
不适用
on-invasive diagnosis and monitoring of non-alcoholic fatty liver disease in bariatric surgical patientsObesityACTRN12615000875505Centre for Obesity Research and Education, Monash University190
进行中（未招募）
Unknown
A healthy volunteer study to determine the effectiveness of a needle-free test for the diagnosis of adrenal insufficiencyAdrenal insufficiencyNutritional, Metabolic, EndocrineISRCTN62724177Sheffield Children's NHS Foundation Trust32