UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038143 |
|---|---|
| Receipt number | R000043476 |
| Scientific Title | Development and Evaluation of the Antenatal Education Material to Improve Prevention of Pregnancy Complication Using ICT in Tanzania |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2022/01/06 14:24:28 |
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Basic information
Public title
Development and Evaluation of the Antenatal Education Material to Improve Prevention of Pregnancy Complication Using ICT in Tanzania
Acronym
Evaluation of midwifery ICT education in Tanzania
Scientific Title
Development and Evaluation of the Antenatal Education Material to Improve Prevention of Pregnancy Complication Using ICT in Tanzania
Scientific Title:Acronym
Evaluation of midwifery ICT education in Tanzania
Region
| Africa |
Condition
Condition
Pregnancy complications
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Therefore, this research aims to evaluate the effect 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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The 38 items of the questionnaire include knowledge about safe pregnancy and danger signs, attitude toward behavior related to pregnancy and childbirth, subjective norm, perceived behavioral control, and intention for the childbirth. They will be measured at the baseline and the outcome approximately 3 months after the baseline.
Key secondary outcomes
Mini quiz to measure knowledge improvement among nurses/midwives and 23 items on women-centered care. At the intervention, after nurses/midwives download the App, they can take pre-test, and they can take post-test one month after starting using the App.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
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
The mobile phone App contains antenatal educational movie that teaches pregnant women and their family the importance of birth preparation and family integration to achieve safe delivery. The smartphone App 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
For the control group, pregnant women receive regular 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 with no severe physical and psychological illness, 16 years old or older, and able to reach Kiswahili. The health institution will be randomly assigned either the intervention group or the control group.
Key exclusion criteria
Those who are currently not pregnant, have physical and mental illness under treatment, are under 16, cannot understand Kiswahili language. Also, if a midwife does not own a smartphone, she will be excluded from the study.
Target sample size
720
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Shimpuku |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
6068507
Address
53 Shogoin-kawaharacho, Sakyoku, Kyoto
TEL
0757513901
shimpuku.yoko.5n@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Shimpuku |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
6068507
Address
53 Shogoin-kawaharacho, Sakyoku, Kyoto
TEL
0757513901
Homepage URL
shimpuku.yoko.5n@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Muhimbili University of Health and Allied Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School of Medicine Ethics Committee
Address
Yoshida-konoecho, Sakyoku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2019 | Year | 10 | Month | 01 | 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
| 2019 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 09 | Month | 28 | Day |
Last modified on
| 2022 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043476
