UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061649 |
|---|---|
| Receipt number | R000070119 |
| Scientific Title | Development and Evaluation of an Interconception Care Educational Program on Hypertensive Disorders of Pregnancy for Postpartum Women: A Feasibility Study |
| Date of disclosure of the study information | 2026/05/25 |
| Last modified on | 2026/05/25 15:37:38 |
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Basic information
Public title
Development and Evaluation of an Interconception Care Educational Program on Hypertensive Disorders of Pregnancy for Postpartum Women
Acronym
Interconception Care Educational Program on Hypertensive Disorders of Pregnancy for Postpartum Women
Scientific Title
Development and Evaluation of an Interconception Care Educational Program on Hypertensive Disorders of Pregnancy for Postpartum Women: A Feasibility Study
Scientific Title:Acronym
Development and Evaluation of an Interconception Care Educational Program on Hypertensive Disorders of Pregnancy for Postpartum Wome
Region
| Japan |
Condition
Condition
Hypertensive Disorders of Pregnancy
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Develop an educational program on interconception care aimed at improving knowledge and preventing hypertensive disorders of pregnancy among women with prior childbirth experience, and evaluate its acceptability and feasibility from the perspectives of both postpartum women and midwives, while also exploratorily examining its limited effectiveness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
program completion rate
Key secondary outcomes
1. Women with prior childbirth experience
Quantitative evaluation
Acceptability: program satisfaction, intention to continue use, intention to recommend
Feasibility: recruitment rate, frequency and extent of use of educational materials, attrition rate
Limited effectiveness: knowledge test scores, number of health behavior items, implementation rate for each health behavior item, categories of items (diet, exercise, breastfeeding, others), and other relevant indicators
Qualitative evaluation
Overall evaluation of the program, satisfaction, ease of understanding of the content, changes in health behaviors, perceptions of the learning content, appropriateness of the timing and method of material distribution, and areas for improvement
2. Midwives
Qualitative evaluation
Overall evaluation of the program, facilitation of the discussion sessions, feasibility of the program, and its impact on participants' health behaviors
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participation in an educational program (the "HDP Future Project") consisting of the provision of a pamphlet and video materials on hypertensive disorders of pregnancy, followed by a midwife-led discussion session after completion of the learning materials.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Women with prior childbirth experience
Inclusion criteria
Women who have had a childbirth experience within the past 3 years
Women who have provided informed consent to participate in this study
Women who are able to understand and respond to questionnaires written in Japanese
Women who are able to use the internet
2. Midwives
Midwives who cooperated in this program as research assistants and have at least 3 years of clinical experience
Key exclusion criteria
No exclusion criteria were applied in this study.
Target sample size
77
Research contact person
Name of lead principal investigator
| 1st name | MAYA |
| Middle name | |
| Last name | GODA |
Organization
St.Luke's international university
Division name
Graduate School of Nursing Science
Zip code
104-8560
Address
9-1 Akashicho Chuo Tokyo
TEL
03-3541-5151
24dn008@slcn.ac.jp
Public contact
Name of contact person
| 1st name | MAYA |
| Middle name | |
| Last name | GODA |
Organization
St.Luke's international university
Division name
Graduate School of Nursing Science
Zip code
104-8560
Address
9-1 Akashicho Chuo Tokyo
TEL
03-3541-5151
Homepage URL
24dn008@slcn.ac.jp
Sponsor or person
Institute
St.Luke's international university
Institute
Department
Personal name
Funding Source
Organization
KIMURA FOUNDATION FOR NURSING EDUCATION
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.Luke's international university
Address
9-1 Akashicho Chuo Tokyo
Tel
03-3541-5151
24dn008@slcn.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 | 05 | Month | 25 | 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 | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 30 | 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 | 05 | Month | 21 | Day |
Last modified on
| 2026 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070119
