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Prenatal Screening for Down Syndrome and Chromosomal Anomalies (PEGASUS-2 Trial)

N/A

Waitlist Available

Led By Francois Rousseau, MD MSc FRCPC

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at weeks of gestation 10-13, 16 and 22

Awards & highlights

PEGASUS-2 Trial Summary

This trial will compare the effectiveness of two different types of prenatal screening for trisomy 21 (Down syndrome) and other chromosome anomalies.

Who is the study for?

This trial is for pregnant women who are 19 or older, between 10-13+6 weeks into their pregnancy as confirmed by ultrasound or last menstrual period. They should want prenatal screening but not be planning to pay for NIPT themselves. Women with known genetic conditions, fetal anomalies at recruitment time, twin demise, or multiple pregnancies cannot participate.Check my eligibility

What is being tested?

The study is testing if first-tier Non-invasive Prenatal Screening (NIPS) can replace traditional tests for detecting trisomy 21 and other chromosome abnormalities in fetuses. It compares the effectiveness of first-tier NIPS against second-tier NIPS and integrated prenatal screening in a large group of pregnant women.See study design

What are the potential side effects?

Since this trial involves non-invasive blood tests, side effects are minimal but may include discomfort from blood draw such as dizziness or bruising at the puncture site. Invasive testing if pursued later could carry risks like miscarriage.

PEGASUS-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at weeks of gestation 10-13, 16 and 22

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at weeks of gestation 10-13, 16 and 22

This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks of gestation 10-13, 16 and 22 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gestational age at diagnosis

Secondary outcome measures

Change in PROMIS Emotional Distress - Anxiety - Short Form 8a Score

Change in PROMIS-29 Score

Gestational age at negative screening result

+6 more

PEGASUS-2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: First-tier NIPSExperimental Treatment2 Interventions

For the intervention arm (1st tier NIPS) women will receive First-tier Non-invasive prenatal screening (NIPS) i.e. provide a blood sample between 10-13+5 weeks gestation with NIPS results within 7 - 10 days of sample collection. Ultrasound examination in first and second trimester will be done based on clinical care practice ordered by health care provider. In case of a failed NIPS test (expected to be between 2% and 4% of samples), a new blood sample will be drawn for NIPS retest as well as for a traditional SIPS(serum integrated prenatal screening) or QUAD(quadruple marker prenatal screening) screen (depending on gestational age). Pregnant women with a positive NIPS test will be offered Invasive prenatal testing for fetal aneuploidy (fetal chromosome analysis).

Group II: Standard of care (2nd tier NIPS)Active Control3 Interventions

For the standard-of-care arm (2nd tier NIPS) women will undergo Traditional integrated prenatal screening i.e. traditional biochemical (+/- NT) and those with a positive screen for T21 or T18 will be offered Second-tier Non-invasive prenatal screening (NIPS) (for T21, T18, T13) or Invasive prenatal testing for fetal aneuploidy. Ultrasound examination in first and second trimester will be done based on clinical care practice ordered by health care provider. Pregnant women with a positive NIPS test will be offered Invasive prenatal testing for fetal aneuploidy (fetal chromosome analysis).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of British ColumbiaOTHER

1,415 Previous Clinical Trials

2,459,167 Total Patients Enrolled

2 Trials studying Aneuploidy

2,100 Patients Enrolled for Aneuploidy

Ottawa Hospital Research InstituteOTHER

561 Previous Clinical Trials

2,777,842 Total Patients Enrolled

Laval UniversityOTHER

417 Previous Clinical Trials

164,423 Total Patients Enrolled

Media Library

First-tier Non-invasive prenatal screening (NIPS) Clinical Trial Eligibility Overview. Trial Name: NCT03831256 — N/A

Aneuploidy Research Study Groups: First-tier NIPS, Standard of care (2nd tier NIPS)

Aneuploidy Clinical Trial 2023: First-tier Non-invasive prenatal screening (NIPS) Highlights & Side Effects. Trial Name: NCT03831256 — N/A

First-tier Non-invasive prenatal screening (NIPS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03831256 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any enrollees in this experiment currently?

"According to clinicaltrials.gov, this trial remains open for recruitment and was initially published on January 13th 2020 with the last update occurring on January 28th 2022."

Answered by AI

How many healthcare settings are currently participating in this experiment?

"This clinical trial has 6 available locations, such as the Kelowna Regional Fertility Center in Kelowna and Prince Rupert Regional Hospital in Prince Rupert. In addition, CHU de Québec - Université Laval is located in Québec City with other sites scattered across North America."

Answered by AI

How many participants have gained admittance to this medical experiment?

"Affirmative, the clinicaltrials.gov database suggests that this experiment is still recruiting members. It was first published on January 13th 2020 and has been updated most recently on January 28th 2022. The study requires 7500 new participants to be recruited from 6 distinct locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PErsonalized Genomics for Prenatal Abnormalities Screening USing Maternal Blood

François Rousseau 2020. "PErsonalized Genomics for Prenatal Abnormalities Screening USing Maternal Blood". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03831256.