onInvasive Prenatal Diagnosis - DNA TEsting on fetal Cells from the Cervix

Recruiting

• Conditions: Congenital Abnormalities; Genetic disorders; 10083624

• Registration Number: NL-OMON54115
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1) 18 years old or above.
2) Have an indication for CVS sampling or amniocentesis.
3) Pregnant with a gestational age between 10 and 22 weeks.
4) Signed written informed consent

Exclusion Criteria

1) minder dan 24 uur de tijd tussen de momenten van het verkrijgen van de
studie informatie en de CVS of vruchtwaterpunctie

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Establishing a robust laboratory protocol for processing samples.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>2. Sequential sampling of up to 100 samples, with as stopping criterion that<br /><br>less than 10 failures are observed in 100 samples. Failures are cases where<br /><br>less than 300 fetal cells are obtained admixed with no more than 60 maternal<br /><br>cells.<br /><br>3. Quality and quantity of DNA for genetic testing using DTECC samples</p><br>