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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after the intervention
Awards & highlights
PEGASUS-II Trial 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.
PEGASUS-II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the 23rd week of pregnancy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the 23rd week of pregnancy
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 morePEGASUS-II 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.
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Who is running the clinical trial?
CHU de Quebec-Universite LavalLead Sponsor
167 Previous Clinical Trials
106,177 Total Patients Enrolled
1 Trials studying Decision Aids
70 Patients Enrolled for Decision Aids
France Légaré, Ph.DPrincipal InvestigatorLaval University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I (or my partner) can verbally agree or sign to join the study.A health professional is involved in my prenatal screening decisions.My partner and I have not decided on prenatal testing for trisomy 21, 18, or 13.I am not pregnant or have any pregnancy-related medical issues.I understand French or English and agree to join the study.Medical residents and interns in midwifery practice referred by prenatal services can participate.I am 18 or older and pregnant or the partner of someone who is pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention introduced to group 1
- Group 2: Intervention introduced to group 2
- Group 3: Intervention introduced to group 3
- Group 4: Intervention introduced to group 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled positions in this research trial?
"Affirmative. Per the details available on clinicaltrials.gov, this medical study commenced recruitment for participants since February 1st 2023 and has had a recent update in May 12th 2023. A total of 980 individuals are needed to be enrolled from one single site."
Answered by AI
How many participants are enrolled in this clinical research project?
"Affirmative, clinicaltrials.gov reveals that the search for participants is ongoing; this study was posted on February 1st 2023 and has been amended as of May 12th 2023. It needs 980 volunteers from one medical centre."
Answered by AI
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