UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062362 |
|---|---|
| Receipt number | R000070790 |
| Scientific Title | Woman-centred Care Implementation and Mobile Learning for Midwifery Education Study |
| Date of disclosure of the study information | 2026/07/28 |
| Last modified on | 2026/07/28 16:15:22 |
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Basic information
Public title
Cross-Cultural Adaptation and Evaluation of a Mobile Learning Application for Midwifery Education: A Mixed-Methods Implementation Study on Woman-Centred Care in Zambia
Acronym
Zambia Woman-Centred Care Mobile Learning Study
Scientific Title
Woman-centred Care Implementation and Mobile Learning for Midwifery Education Study
Scientific Title:Acronym
Cross-cultural Adaptation of a Mobile Learning Application for Midwives and Assessment of Woman-Centred Care Practice Competence
Region
| Africa |
Condition
Condition
Woman-Centred Care during Pregnancy and Childbirth
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to culturally adapt a mobile learning application for Woman-Centred Care (WCC), originally developed in Tanzania, to the Zambian context and to evaluate its feasibility and effectiveness. The study will also examine, using a mixed-methods approach, its effects on midwives' knowledge, attitudes, and practices, as well as on the care received by pregnant women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in Woman-Centred Care Scale (WCC23-E) score from baseline to the end of the 8-week educational intervention.
Key secondary outcomes
1. Knowledge assessment (mini-quiz) scores on Woman-Centred Care, measured at baseline and after the 8-week intervention.
2. Application usage data (access frequency, duration of use, and module completion rate), recorded throughout the intervention period.
3. Usability and user experience of the mobile learning application, assessed after the 8-week intervention.
4. Feasibility of the intervention, evaluated through focus group discussions conducted after completion of the intervention.
5. Pregnant women's birth preparedness, maternal health knowledge, and care-related outcomes, assessed after completion of the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Midwives in the intervention group will receive access to a culturally adapted Woman-Centred Care (WCC) mobile learning application for Zambia for 8 weeks. The application contains educational content based on WHO guidelines and practical guidance for integrating health education into routine antenatal care. Participants may use the application throughout the intervention period. Application usage (access frequency, duration of use, and module completion rate) will be recorded. Knowledge assessments will be conducted before and after the intervention, and usability and user experience will be explored through focus group discussions after completion of the intervention.
Interventions/Control_2
Midwives in the control group will receive no study intervention during the intervention period and will continue providing routine antenatal care. Access to the mobile learning application will not be provided during the study period.
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
Male and Female
Key inclusion criteria
Midwives
1.Registered midwives working in the antenatal care clinic or maternity ward of the intervention facilities.
2.Willing to participate in the study.
3.Able to use a smartphone or other digital learning device.
Pregnant women
1.In the second trimester of pregnancy or later.
2.Receiving antenatal care at one of the participating study facilities.
3.Aged 18 years or older.
4.Willing to participate and able to provide written informed consent.
Key exclusion criteria
Individuals who do not meet the inclusion criteria or who withdraw their consent to participate during the study.
Target sample size
428
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Shimpuku |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences Program of Health Sciences
Zip code
734-8553
Address
1 Chome-2-3 Kasumi, Minami Ward, Hiroshima, 734-8551
TEL
082-257-5555
yokoshim@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Shimpuku |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences Program of Health Sciences
Zip code
734-8553
Address
1 Chome-2-3 Kasumi, Minami Ward, Hiroshima, 734-8551
TEL
82-257-5555
Homepage URL
yokoshim@hiroshima-u.ac.jp
Sponsor or person
Institute
University of Zambia
Institute
Department
Personal name
Lonia Mwape
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Certified Review Board
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, Japan
Tel
082-257-1551
iryo-sinsa@office.hiroshima-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 | 07 | Month | 28 | 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 | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | 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 | 07 | Month | 28 | Day |
Last modified on
| 2026 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070790
