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Decision Aid Strategies for Prenatal Trisomy Screening (PEGASUS-II Trial)

N/A
Recruiting
Led By France Légaré, Ph.D
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
Must not have
Pregnant women with any medical complications associated or not with pregnancy (e.g. diabetes, hypertension, multiple pregnancy) are not eligible for this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after the intervention
Awards & highlights

Summary

This trial studies the effects of a decision aid to help pregnant women, partners, and health professionals make decisions about prenatal screening. It aims to measure involvement in decision-making, and usage of the aid.

Who is the study for?
This trial is for pregnant women and their partners in Quebec who haven't decided on prenatal testing for trisomy conditions. Eligible participants must be adults followed by certain health facilities, able to understand French or English, and give consent. Excluded are those with pregnancy complications or health professionals working at multiple sites.Check my eligibility
What is being tested?
The study tests how well a decision aid (DA) helps people make shared decisions about prenatal screening for trisomies 21, 18, and 13. It measures the involvement of expectant mothers, partners, and healthcare providers in decision-making.See study design
What are the potential side effects?
Since this trial involves a non-medical intervention (a decision aid), there are no direct physical side effects associated with drugs or medical procedures.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant or have any pregnancy-related medical issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the 23rd week of pregnancy
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the 23rd week of pregnancy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Level of SDM adoption
Secondary outcome measures
Appreciation of the online SDM training
DA appreciation
DA use fidelity for healthcare providers
+10 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Intervention introduced to group 4Experimental Treatment1 Intervention
The intervention is introduced to the fourth group (G4) of clusters and G1, G2 and G3 remains in intervention conditions.
Group II: Intervention introduced to group 3Experimental Treatment1 Intervention
The intervention is introduced to the third group (G3) of clusters and G1 and G2 remains in intervention conditions.
Group III: Intervention introduced to group 2Experimental Treatment1 Intervention
The intervention is introduced to the second group (G2) of clusters and G1 remains in intervention conditions.
Group IV: Intervention introduced to group 1Experimental Treatment1 Intervention
The intervention is introduced to the first group (G1) of clusters.

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor
168 Previous Clinical Trials
106,521 Total Patients Enrolled
1 Trials studying Decision Aids
70 Patients Enrolled for Decision Aids
France Légaré, Ph.DPrincipal InvestigatorLaval University

Media Library

DA Scaling Strategies Clinical Trial Eligibility Overview. Trial Name: NCT05859139 — N/A
Decision Aids Research Study Groups: Intervention introduced to group 1, Intervention introduced to group 2, Intervention introduced to group 3, Intervention introduced to group 4
Decision Aids Clinical Trial 2023: DA Scaling Strategies Highlights & Side Effects. Trial Name: NCT05859139 — N/A
DA Scaling Strategies 2023 Treatment Timeline for Medical Study. Trial Name: NCT05859139 — N/A
~406 spots leftby Jul 2025
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