UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061286 |
|---|---|
| Receipt number | R000068423 |
| Scientific Title | Decision Aid Intervention for Prenatal Testing: A Randomized Pilot Trial |
| Date of disclosure of the study information | 2026/04/17 |
| Last modified on | 2026/04/17 11:31:07 |
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Basic information
Public title
Decision Aid Intervention for Prenatal Testing: A Randomized Pilot Trial
Acronym
"Evaluation of Decision Aid-Based Support for Prenatal Testing
Scientific Title
Decision Aid Intervention for Prenatal Testing: A Randomized Pilot Trial
Scientific Title:Acronym
DA-PRENT Pilot
Region
| Japan |
Condition
Condition
Pregnancy
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Feasibility evaluation of decision support intervention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
Key secondary outcomes
Estimation of effect size on Decision Conflict Scale (DCS) for sample size calculation in a future definitive RCT
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Rie |
| Middle name | |
| Last name | Notomi |
Organization
St. Luke's International University Graduate School
Akita University Hospital
Division name
Nursing Department
Zip code
010-8543
Address
44-2 Hasunuma, Hiromen, Akita City, Akita Prefecture
TEL
018-834-1111
24dn016@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Notomi |
Organization
St. Luke's International University Graduate School , Akita University Hospital
Division name
Nursing Department
Zip code
010-8543
Address
44-2 Hasunuma, Hiromen, Akita City, Akita Prefecture
TEL
018-884-6575
Homepage URL
24dn016@slcn.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita University Hospital
Address
44-2 Hasunuma, Hiromen, Akita City, Akita Prefecture
Tel
018-833-1166
soken@hos.akita-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 17 | Day |
Last modified on
| 2026 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068423
