UMIN-CTR Clinical Trial

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
Email	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
Email	shimpuku.yoko.5n@kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043476