NL-OMON50448
Recruiting
Not Applicable
on invasive prenatal testing (NIPT) of fetal genetic disorders in maternal blood - NIPT genetic disorders
Medisch Universitair Ziekenhuis Maastricht0 sites400 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- genetic disorders
- Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Enrollment
- 400
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\- 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\)
Outcomes
Primary Outcomes
Not specified
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