UMIN-CTR Clinical Trial

Basic information
Public title	Mobile-health tool to improve maternal and neonatal health care in rural Bangladesh: a cluster randomized controlled trial with economic evaluation
Acronym	Cluster RCT for maternal and neonatal m-Health in rural Bangladesh
Scientific Title	Mobile-health tool to improve maternal and neonatal health care in rural Bangladesh: a cluster randomized controlled trial with economic evaluation
Scientific Title:Acronym	Cluster RCT for maternal and neonatal m-Health in rural Bangladesh
Region	Asia(except Japan)

Condition
Condition	maternal and neonatal mortality and morbidities, utilization of perinatal cares, referral
Classification by specialty	Not applicable Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effectiveness of a mobile health program on maternal and neonatal health outcomes and utilization of perinatal care
Basic objectives2	Others
Basic objectives -Others	To assess the effectiveness of Maternal and Child Handbook strengthened by mobile short message platform
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	maternal and neonatal mortality and morbidities
Key secondary outcomes	utilization of perinatal care, referral

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention: Antenatal and neonatal care stregthened by applying mobile platform and maternal and child health handbook
Interventions/Control_2	Control: Regular antenatal and neonatal 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	15 years-old <=
Age-upper limit	49 years-old >=
Gender	Female
Key inclusion criteria	Same as the intervention group
Key exclusion criteria	Same as the intervention group
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Ruoyan Middle name Last name Gai
Organization	National Center for Child Health and Development
Division name	Division of Policy Evaluation, Department of Health Policy
Zip code	1578535
Address	Okura 2-10-1 Setagaya-ku 1578535 Tokyo
TEL	03-3416-0181
Email	gai-r@ncchd.go.jp

Public contact
Name of contact person	1st name Ruoyan Middle name Last name Gai
Organization	National Center for Child Health and Development
Division name	Division of Policy Evaluation, Department of Health Policy
Zip code	1578535
Address	Okura 2-10-1 Setagaya-ku 1578535 Tokyo
TEL	03-3416-0181
Homepage URL
Email	gai-r@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
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	- UChicago Research Bangladesh - Bridge of Community Development Foundation
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center for Child Health and Development
Address	Okura 2-10-1 Setagaya-ku 1578535 Tokyo
Tel	03-3416-0181
Email	gai-r@ncchd.go.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	2017 Year 04 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	3002
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	No longer recruiting
Date of protocol fixation	2016 Year 12 Month 28 Day
Date of IRB	2016 Year 12 Month 19 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2018 Year 11 Month 30 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 30 Day
Date analysis concluded	2019 Year 12 Month 30 Day

Other
Other related information

Management information
Registered date	2017 Year 01 Month 11 Day
Last modified on	2019 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026170