PErsonalized Genomics for Prenatal Abnormalities Screening USing Maternal Blood

Not Applicable

Active, not recruiting

• Conditions: Prenatal Disorder; Aneuploidy

• Registration Number: NCT03831256
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-1-21
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 7849

Inclusion Criteria

Inclusion Criteria:<br><br> - Pregnant women 19 years or older wanting prenatal screening<br><br> - 10-13+6 wks determined by dating ultrasound or last menstrual period.<br><br> - Not intending to pursue self pay NIPT<br><br>Exclusion Criteria:<br><br> - Known fetal anomaly at the time of recruitment<br><br> - Multiple gestation<br><br> - Known twin demise<br><br> - Planned CVS or amnio for known genetic condition.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gestational age at diagnosis

Secondary Outcome Measures

Name	Time	Method
Gestational age at positive screening result;proportion of women with no results;numbers of days for women with false positive result of screen to wait for result of definite test;Change in PROMIS-29 Score;Change in PROMIS Emotional Distress - Anxiety - Short Form 8a Score;Patient-Reported Experience Measure (PREM) - Score;gestational age at termination of pregnancy;percentage of women undergoing invasive diagnostic testing;Gestational age at negative screening result