- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06543784
Preconception Carrier Screening at the Erasmus MC
The New Wave of Preconception Carrier Screening: the Nurse Practitioner in the Lead?
Rationale A recent advisory report by the 'Health Council' has recommended that all prospective parents should have the opportunity to undergo preconception carrier screening. Consequently,there will no longer be any prerequisites for referring a couple. It is expected that there will be an increase in the number of prospective parents seeking counseling for preconception carrier screening. This is anticipated to result in an increase in the number of referrals, leading to several points of attention.
Objective(s) The aim of the research is to gather insights, perspectives, and experiences from healthcare professionals and prospective parents in order to design a care pathway for offering preconception carrier screening at Erasmus MC and the Rotterdam region. This will also include examining the role that nurse practitioners can play in this offering.
Study Overview
Status
Conditions
Detailed Description
Study type Exploratory research. Study population Healthcare professionals involved in preconception carrier screening and potential prospective parents who might want to undergo preconception carrier screening in the future. Methods Semi-structured interviews and focus groups will be used to explore topics which will be audio recorded and transcribed verbatim. The results will be analyzed by two to three researchers independently following the principles of grounded theory.
Burden and risks There are no risks associated with this research. For the interviewees and participants of the focus groups there is the burden of time investment. Recruitment and consent Health care professionals and potential prospective parents will be asked for participation in the study by the treating physician. If they consent to be approached, they will be informed about the study and contacted by the researcher. If willing to participate, an appointment for the interview/focus group is scheduled. Before the start of the interview/focus group, signed informed consent will be obtained.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Rotterdam, Netherlands
- Recruiting
- Erasmus MC
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Contact:
- Jozephien Robbemont
- Phone Number: 0031650023674
- Email: j.robbemont@erasmusmc.nl
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Health care professionals working with potential prospective parents.
- Potential prospective parents who might want to undergo preconception carrier screening in the future.
Exclusion Criteria:
- (Dutch) language proficiency not sufficient.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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General practitioners
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Experts of experience
Health care professionals involved in preconception carrier screening at Amsterdam UMC, UMC Groningen and Australia
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Gynaecologists (in training)
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Midwives
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Nurse practitioners and/or clinical geneticists
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Potential prospective patients who might want to undergo preconception carrier screening
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Creating a pathway for preconception carrier screening using focus groups and interviews.
Time Frame: 1 year
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Using focus groups and interviews to gather insights, perspectives, and experiences from healthcare professionals and prospective parents in order to design a care pathway for offering preconception carrier screening at Erasmus MC and the Rotterdam region.
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1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 12716
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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