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Clinical Trials/NL-OMON50448
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
Medisch Universitair Ziekenhuis Maastricht

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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