Decision Aid Intervention for Prenatal Testing: A Randomized Pilot Trial

Decision Aid Intervention for Prenatal Testing: A Randomized Pilot Trial - DA-PRENT Pilot

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061286

Enrollment

Registered

2026-04-17

Start date

2026-04-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Interventions

Intervention Group: Decision Aid and Genetic counseling Participants receive the Decision Aid booklet (&quot

Guide for Thinking About Prenatal Testing&quot

) by mail prior to their scheduled genetic counseling appointment at an NIPT-certified facility, followed by standard genetic counseling. Control Group :Genetic counseling only Participants receive s

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1.Recruitment: At least 80% of target (at least 30 participants) in 6 months 2.Retention: At least 80% at T2, at least 70% at T3 (DCS completion) 3.Questionnaire completion: At least 90% among retained participants 4.DA acceptability: (a) At least 70% satisfaction 4 or higher (out of 5), (b) At least 80% recommendation willingness, (c) Mean Preparation for Decision Making 3.5 or higher (out of 5) 5.Intervention fidelity: At least 80% protocol adherence	—

Measure

Time frame

1.Recruitment: At least 80% of target (at least 30 participants) in 6 months 2.Retention: At least 80% at T2, at least 70% at T3 (DCS completion) 3.Questionnaire completion: At least 90% among retained participants 4.DA acceptability: (a) At least 70% satisfaction 4 or higher (out of 5), (b) At least 80% recommendation willingness, (c) Mean Preparation for Decision Making 3.5 or higher (out of 5) 5.Intervention fidelity: At least 80% protocol adherence

—

Secondary

Measure	Time frame
Estimation of effect size on Decision Conflict Scale (DCS) for sample size calculation in a future definitive RCT	—

Countries

Japan

Contacts

Public ContactRie Notomi

St. Luke's International University Graduate School , Akita University Hospital Nursing Department

24dn016@slcn.ac.jp018-884-6575

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026