UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025628 |
|---|---|
| Receipt number | R000026170 |
| Scientific Title | Mobile-health tool to improve maternal and neonatal health care in rural Bangladesh: a cluster randomized controlled trial with economic evaluation |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2019/09/20 11:33:58 |
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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
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
gai-r@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
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
- 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026170
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
