NL-OMON50448招募中不适用
on invasive prenatal testing (NIPT) of fetal genetic disorders in maternal blood - NIPT genetic disorders
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 400 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Pregnant women and their partners (18+) of which:
- •Group 1: the woman is pregnant after PGD for a chromosomal anomaly or monogenic
- •Group 2: the fetus is at risk for a chromosomal anomaly because of an adverse
- •result of regular NIPT testing (Dutch TRIDENT-1 or -2 study) for aneuploidy
- •with or without additional findings.
- •Group 3: the foetus is at high risk of having a de novo disorder on the basis
- •of ultrasonography findings and couple will undergo PND
- •Group 4: the fetus is at high risk of having inherited a dominant or recessive
- •disorder of his/her affected parent(s) and couple ask for conventional PND
- •- the pregnant woman and partner are 18 years or older
- •- the pregnant woman has sufficient understanding of Dutch language and is
- •able to give informed consent.
排除标准
- •- in the opinion of the treating physician psychological distress is so severe
- •that asking for participation is not safe.
- •- the pregnant woman is treated for a malignancy
- •- patients in group 1 (testing performed with only PCR or OnePGT for monogenic
- •disorders), group 3 and 4 will be excluded from this study if they do not opt
- •for NIPT (with/without additional findings) or PND (with at least a QF PCR of
- •chromosomes 13, 18, 21)
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