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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046562
Receipt No. 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 2022/01/06

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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
Obsterics 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
Email 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
Email yokoshim@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

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
Email 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 Open public recruiting
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
2023 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
2022 Year 01 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052577

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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