MedPath

Research on the validation and acceptance of Non-Invasive Prenatal Diagnosis (NIPD) as a safe and reliable alternative for invasive prenatal testing for monogenic disorders.

Recruiting
Conditions
cystic fibrosis
Duchenne or one of the serious recessive diseases present in a genetically isolated population
hemophilia
sickle cell anemia
Spinal Muscular Dystrophy
thalassemia
10027664
Registration Number
NL-OMON45858
Lead Sponsor
Hubrecht Instituut, KNAW
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
120
Inclusion Criteria

* Pregnant couples (or couples planning a pregnancy) at increased risk (25%) of carrying a child with one of the following severe monogenic recessive diseases (thalassemia, sickle cell anemia, cystic fibrosis, hemophilia, Spinal Muscular Dystrophy, Duchenne or one of the serious recessive diseases present in a genetically isolated population) AND opting for PND (or postnatal cord blood).
OR
* Pregnant couples (or couples planning a pregnancy) from a genetically isolated population with one partner carrier of a severe recessive disease (+/-couples).

Exclusion Criteria

* Multiple gestation/vanished twin/empty sac(s) detected at any time before blood sampling during pregnancy
* Maternal age <18 years
* Insufficient knowledge of Dutch or English language or impossibility to understand the study purpose.
* Women carrier of an X-linked recessive disorder and pregnant of a girl.
* Gestational age > 14 weeks

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath