UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046562 |
|---|---|
| Receipt number | R000052577 |
| Scientific Title | Development and Evaluation of the Simple and Easy Antenatal Education Using a Mobile Phone App in Tanzania |
| Date of disclosure of the study information | 2022/01/06 |
| Last modified on | 2023/07/11 10:14:49 |
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Basic information
Public title
Development and Evaluation of the Simple and Easy Antenatal Education
Using a Mobile Phone App in Tanzania
Acronym
ICT education research in Tanzania
Scientific Title
Development and Evaluation of the Simple and Easy Antenatal Education
Using a Mobile Phone App in Tanzania
Scientific Title:Acronym
ICT education research in Tanzania
Region
| Africa |
Condition
Condition
Pregnancy
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research aims to evaluate the effect of the package of the mobile phone App containing the new WHO guideline for antenatal care and the educational materials to teach danger signs and safe delivery "Nne na Tano" to maximize health of pregnant women, and reminders of health education and antenatal care visits for pregnant women with respect to knowledge and attitude about healthy pregnancy and their intention of giving birth with skilled birth attendants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Thirty-eight items designed to investigate factors, knowledge, attitudes, subjective norms, perceived behavioral control, associated with intentions of birthplace. The timing of measurement was set at the beginning of the study as a baseline survey and at thirty-six gestational weeks of the subjects as an outcome survey.
Key secondary outcomes
Mini-quiz to improve knowledge of midwives/nurses with ten items and twenty-three items of Women-Centered Care Questionnaire for pregnant women. As for midwives/nurses, when the baseline is over and midwives/nurses download the app, they will be administered twice: a pre-test before learning the content, and a post-test after learning the content after a month of study. As for pregnant women, the baseline survey will be conducted at the beginning of the study and the outcome study will be conducted at the thirty-six-week gestation of the participants.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
The intervention group: The mobile phone App has two versions for pregnant women and midwives. The pregnant women version contains antenatal educational contents that teaches pregnant women and their family the importance of birth preparation and family integration to achieve safe delivery. The midwife version is named Midwifery Up! aiming to update the knowledge of midwives so that they can provide proper information and care for pregnant women in timely manner. Midwifery Up! will contain movies to teach pregnant women about danger signs, a calculator of expected due date, WHO recommendations on antenatal care for positive pregnancy experience. A Forum page will be created for midwives and doctors as well as pregnant women can discuss local health knowledge and behaviors.
Interventions/Control_2
The control group received a regular antenatal care.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
The inclusion criteria for women are: currently pregnant of 2nd or 3rd trimester, 16 years old or older, and able to read Kiswhaili.
Key exclusion criteria
The exclusion criteria for women are: currently not pregnant, less than 16 years old, not able to Kiswahili, and no access to a smart phone.
Target sample size
720
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
Zip code
734-8551
Address
1-2-3 Kasumi Minami-ku, Hiroshima
TEL
0822575555
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
Zip code
734-8551
Address
1-2-3 Kasumi Minami-ku, Hiroshima
TEL
0822575555
Homepage URL
yokoshim@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Sciences
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Muhimbili University of Health and Allied Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University
Address
1-2-3 Kasumi Minami-ku, Hiroshima
Tel
0822575555
iryo-seisaku@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
| 2022 | Year | 01 | Month | 06 | 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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2022 | Year | 01 | Month | 06 | Day |
Last modified on
| 2023 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052577
