UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061527 |
|---|---|
| Receipt number | R000070404 |
| Scientific Title | A non-randomized hybrid type 1 effectiveness-implementation study evaluating the introduction of the Maternal and Child Health Handbook in Adjara, Georgia |
| Date of disclosure of the study information | 2026/05/12 |
| Last modified on | 2026/05/11 19:50:15 |
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Basic information
Public title
Study evaluating the introduction of the Maternal and Child Health Handbook on maternal and child healthcare in Georgia
Acronym
Georgia Maternal and Child Health Handbook Study
Scientific Title
A non-randomized hybrid type 1 effectiveness-implementation study evaluating the introduction of the Maternal and Child Health Handbook in Adjara, Georgia
Scientific Title:Acronym
MCH-HB Adjara Study
Region
| Europe |
Condition
Condition
Continuity and quality of maternal and infant healthcare services
Classification by specialty
| Obstetrics and Gynecology | Pediatrics | Nursing |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and implementation of the Maternal and Child Health Handbook (MCH-HB) introduced in the Autonomous Republic of Adjara, Georgia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Completion of at least 8 antenatal care visits during pregnancy
Key secondary outcomes
Postnatal care uptake, infant immunization, Continuum of Care indicators, quality-adjusted coverage indicators, breastfeeding, maternal knowledge, communication and experience of care
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Batumi post-intervention group: women delivering after implementation of the MCH-HB in the project area
Interventions/Control_2
Batumi pre-intervention group: women delivering before implementation of the MCH-HB in the project area
Interventions/Control_3
Kutaisi post-period comparison group: women delivering during the post-intervention period in the comparison site
Interventions/Control_4
Kutaisi pre-period comparison group: women delivering during the pre-intervention period in the comparison site
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women aged 18 years or older who delivered at participating facilities and were able to participate in interviews in the Georgian language
Key exclusion criteria
Stillbirth, surrogate birth, or neonatal death before the survey
Target sample size
1670
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Nanishi |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
7-3-1Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3689
keiko50@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Nanishi |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
7-3-1Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0358413689
Homepage URL
keiko50@m.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan International Cooperation Agency (JICA)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine, The University of Tokyo
Address
7-3-1Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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
All health facilities providing maternal and infant healthcare services in Adjara and Kutaisi, Georgia
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 11 | Day |
Last modified on
| 2026 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070404
