UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028670 |
|---|---|
| Receipt number | R000032824 |
| Scientific Title | Development of Early Essential Newborn Care Basic care course for Indonesian midwives |
| Date of disclosure of the study information | 2017/10/15 |
| Last modified on | 2021/08/27 15:24:33 |
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Basic information
Public title
Development of Early Essential Newborn Care Basic care course for Indonesian midwives
Acronym
Development of EENC basic course for Indonesia
Scientific Title
Development of Early Essential Newborn Care Basic care course for Indonesian midwives
Scientific Title:Acronym
Development of EENC basic course for Indonesia
Region
| Asia(except Japan) |
Condition
Condition
Newborn death
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop the Early Essential Newborn Care basic care course for Indonesian Midwives.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Knowledge score at before and after the program
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Early Essenstial Newborn Care Basic course
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
| 22 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Midwives working for public hospital in Jakarta
Key exclusion criteria
None
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Yasuko |
| Middle name | |
| Last name | Nagamatsu |
Organization
St. Luke's International University
Division name
College of Nursing
Zip code
1040044
Address
10-1 Akashi-cho, Cho-ku, Tokyo
TEL
0355502262
sarah-nagamatsu@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Nagamatsu |
Organization
St. Luke's International University
Division name
College of Nursing
Zip code
1040044
Address
10-1 Akashi-cho, Cho-ku, Tokyo
TEL
0355502262
Homepage URL
sarah-nagamatsu@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
by
Japan Society for Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Lukes International University Research Ethics Committee
Address
10-1 Akashi-cho, Chuo, Tpkyo
Tel
0335415151
kenkyukikaku@luke.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
Syarif Hidayatullah State Islamic University Jakarta (Indonesia)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
http://arch.luke.ac.jp/dspace/bitstream/10285/13514/2/SLIU%206%201-9.pdf
Publication of results
Published
Result
URL related to results and publications
http://arch.luke.ac.jp/dspace/bitstream/10285/13514/2/SLIU%206%201-9.pdf
Number of participants that the trial has enrolled
16
Results
16 Indonesian female midwives (mean age:46.6 years; range36-60) participated. Qualitative analysis of the FGDs yielded three categories of the program;
1)Acceptability as practical program
2)Demand for practical program
3)Barriers and countermeasures for implemantation.
Our modified EENC program fits the settings for Indonesian midwives however there are some barriers. to implementing in the current setting in Indonesia.
Results date posted
| 2021 | Year | 08 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Female midwives with mean age: 46.6 years
Participant flow
Recruited to a hospital
Adverse events
None
Outcome measures
Satisfaction
Knowledge
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 15 | Day |
Last modified on
| 2021 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032824
| 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 |
