Tokyo, April 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061286) titled 'Decision Aid Intervention for Prenatal Testing: A Randomized Pilot Trial' on April 17.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Akita University

Condition: Condition - Pregnancy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Feasibility evaluation of decision support intervention Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention Group: Decision Aid and Genetic counseling Participants receive the Decision Aid booklet ("Guide for Thinking About Prenatal Testing") by mail prior to their scheduled genetic counseling appointment at an NIPT-certified facility, followed by standard genetic counseling. Interventions/Control_2 - Control Group :Genetic counseling only Participants receive standard genetic counseling at NIPT-certified facilities without the Decision Aid intervention.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - Participants must meet all of the following criteria:

Currently pregnant Singleton pregnancy Willing to receive genetic counseling regarding prenatal testing Able to receive genetic counseling at a facility certified by the Committee for the Accreditation System for Prenatal Testing Gestational age of 14 weeks 6 days or less at the time of genetic counseling No previous experience with prenatal testing (maternal serum marker screening, NIPT, chorionic villus sampling, or amniocentesis) Able to read and write in Japanese Able to provide informed consent via smartphone or computer Able to receive the Decision Aid by mail Key exclusion criteria - 1. Multiple pregnancy (twins or higher-order multiples) 2. Unable to receive genetic counseling at a facility certified by the Committee for the Accreditation System for Prenatal Testing 3. Previous experience with any prenatal testing Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 20 Day Date of IRB - 2026 Year 01 Month 21 Day Anticipated trial start date - 2026 Year 04 Month 22 Day Last follow-up date - 2026 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068423

Disclaimer: Curated by HT Syndication.