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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001748
Receipt No. R000002108
Scientific Title A cluster randomised controlled trial of maternal and child health handbook in Mongolia
Date of disclosure of the study information 2009/03/03
Last modified on 2012/02/27

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Basic information
Public title A cluster randomised controlled trial of maternal and child health handbook in Mongolia
Acronym A cluster randomised controlled trial of maternal and child health handbook in Mongolia
Scientific Title A cluster randomised controlled trial of maternal and child health handbook in Mongolia
Scientific Title:Acronym A cluster randomised controlled trial of maternal and child health handbook in Mongolia
Region
Asia(except Japan)

Condition
Condition Maternal and Child Health
Classification by specialty
Obsterics and gynecology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To promote health of women and children especially in high mortality settings ( Bulgan Aimag in Mongolia)
1) To evaluate effectiveness of Maternal and Child Health in Mongolia
2) To assess acceptability of Maternal and Child Health (MCH) Handbook by both families and health care professionals in Mongolia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Number of antenatal care visits
Key secondary outcomes 1)Perception and satisfaction of mother towards maternal and child health care
2)Prerception and knowledge of MCH handbook
3)Health conditons of infant
4)Improvement in maternal mortality and morbility
5)Improvement in perinatal mortality and morbility
6)EPDS(Edinburgh Postnatal Depression Scale)
7)GHQ (Generanl Health Questionnaire)
8)Health behavior of pregant woman or family

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Implementation of MCH Handbooks
Interventions/Control_2 Delayed Implementation
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Mother, her child in maternal child health in Bulgan Aimag , Mongolia
Key exclusion criteria None
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rintaro Mori
Organization Osaka Medical Center and Research Institute for Maternal and Child Health, Japan
Division name WHO Collaborating Centre for Maternal and Child Health
Zip code
Address 840 Murodou-cho, Izumi, Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Rintaro Mori
Organization Osaka Medical Center and Research Institute for Maternal and Child Health, Japan
Division name WHO Collaborating Centre for Maternal and Child Health
Zip code
Address 840 Murodou-cho, Izumi, Osaka
TEL
Homepage URL
Email rintaromori@gmail.com

Sponsor
Institute Osaka Medical Center and Research Institute for Maternal and Child Health, Japan
Institute
Department

Funding Source
Organization International Cooperation Research Grant by Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Center for Health Development, Ministry of Health, Mongolia
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 03 Month 03 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
2009 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 10 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 03 Month 03 Day
Last modified on
2012 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002108

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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