Tokyo, Oct. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059478) titled 'Genetic Counseling to Support Couples' Decision-Making Regarding Prenatal Testing: A Randomized Controlled Trial Using the Ottawa Decision Guide' on Oct. 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Nagasaki University
Condition:
Condition - Couples without children
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to examine support for couples' decision-making regarding prenatal testing. Participants will be randomly assigned, with the intervention group receiving support using the Ottawa Decision Support Guide, and the control group receiving decision-making support without the use of the tool. The study aims to clarify differences between the two groups in decisional conflict, couples' communication attitudes, and the impact of reaching joint decisions on subsequent relationship quality. Findings are expected to inform genetic counseling, genetics education, and preconception care.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The intervention group will receive support for couples' decision-making using the Ottawa Decision Support Guide. The control group will receive decision-making support without using the Ottawa Decision Support Guide.
Interventions/Control_2 - The intervention group will receive support for couples' decision-making using the Ottawa Decision Support Guide. The control group will receive decision-making support without using the Ottawa Decision Support Guide.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Aged 18 years or older
Couples without children
Wife under 50 years of age
Couples married for 10 years or less
Key exclusion criteria - Couples who have children
Individuals who have experienced fertility treatment
Those who have previously received genetic counseling related to NIPT
Individuals who are unable to participate in the study online (e.g., cannot access Zoom or complete web-based questionnaires)
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 03 Day
Date of IRB - 2025 Year 09 Month 04 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067826
Disclaimer: Curated by HT Syndication.
