UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054204 |
|---|---|
| Receipt number | R000061890 |
| Scientific Title | Implementation Study for a Hospital-based Approach to Advanced Midwifery Continuity of Care for Women with Hyperglycemia |
| Date of disclosure of the study information | 2024/04/20 |
| Last modified on | 2024/04/19 21:37:14 |
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Basic information
Public title
Implementation Study for Improving the Quality of Continuity of Care in Midwifery Practice
Acronym
Continuity of Care in Midwifery Practice
Scientific Title
Implementation Study for a Hospital-based Approach to Advanced Midwifery Continuity of Care for Women with Hyperglycemia
Scientific Title:Acronym
Hospital-based Midwifery Continuity Care for Hyperglycemia
Region
| Japan |
Condition
Condition
Gestational Diabetes Mellitus
Overt Diabetes in Pregnancy
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To implement and evaluate an evidence-based continuity of midwifery care program at the antenatal clinic of Hospital A, based on the continuity and coordination of care framework, for promoting continuous care and translating evidence into practice regarding gestational hyperglycemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Knowledge of midwives on care for gestational hyperglycemia, 2.Midwives' experience, confidence, and job satisfaction in caring for gestational hyperglycemia, 3.Breastfeeding rates at discharge and 1-month checkup, weight gain control, and large for gestational age (LGA) birth rate,4.Patient experience and satisfaction, 5.Physicians' clinical workload and healthcare costs, 6.fidelity, 7.feasibility, 8.appropriateness, 9.acceptability, 10.reach
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
This project study is an implementation research aimed at improving the quality of continuous support for women with gestational hyperglycemia by implementing a continuity of midwifery care promotion program at the antenatal clinic of Hospital A, based on the World Health Organization's Continuity and Coordination of Care framework. In this project, a continuity of care program will be implemented for midwives assigned to the antenatal clinic, and they will provide antenatal care to women with gestational hyperglycemia following the care guidelines.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
women diagnosed with gestational hyperglycemia during pregnancy
Key exclusion criteria
pregestational diabetes mellitus
Target sample size
514
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Kato |
Organization
St. Luke's International University
Division name
Graduate School of Nursing
Zip code
104-0044
Address
10-1 Akashi-cho Chuo-ku Tokyo 1040044 JPN
TEL
03-3543-6391
20dn102@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Kato |
Organization
St. Luke's International University
Division name
Graduate School of Nursing
Zip code
104-0044
Address
10-1 Akashi-cho Chuo-ku Tokyo 1040044 JPN
TEL
03-3543-6391
Homepage URL
20dn102@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Mika Kato
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Luke's International University
Address
10-1 Akashi-cho Chuo-ku Tokyo 1040044 JPN
Tel
03-3543-6391
20dn102@slcn.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
| 2024 | Year | 04 | Month | 20 | 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
| 2023 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 19 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061890
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| Registered date | File name |
| Research case data | |
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