UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055427 |
|---|---|
| Receipt number | R000061709 |
| Scientific Title | Evaluation of midwifery care education programs to prevent preterm birth: Feasibility study |
| Date of disclosure of the study information | 2024/09/05 |
| Last modified on | 2024/12/06 05:21:48 |
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Basic information
Public title
Evaluation of midwifery care education programs to prevent preterm birth: Feasibility study
Acronym
Evaluation of midwifery care education programs to prevent preterm birth: Feasibility study
Scientific Title
Evaluation of midwifery care education programs to prevent preterm birth: Feasibility study
Scientific Title:Acronym
Evaluation of midwifery care education programs to prevent preterm birth: Feasibility study
Region
| Japan |
Condition
Condition
preterm birth
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the feasibility of a midwifery care education program to prevent preterm birth.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CPD-reaction questionnaire
Key secondary outcomes
Testing midwifery care knowledge to prevent premature birth
The Evidence-Based Practice Attitude Scale Japanese version
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Attend online interactive educational programs
Interventions/Control_2
Attend educational programs in brochures
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
midwives
Key exclusion criteria
Those who have difficulty understanding Japanese.
Those who have difficulty attending educational programs on-line.
Those who have never had or will never have the opportunity to work with pregnant women as a midwife.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Sachiyo |
| Middle name | |
| Last name | Nakamura |
Organization
Yokohama City University
Division name
Department of Nursing Graduate School of Medicine
Zip code
236-0004
Address
hukuura3-9,kanazawaku,yokohamashi
TEL
0457872548
t236702e@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kidera |
Organization
Yokohama City University
Division name
Department of Nursing Graduate School of Medicine
Zip code
236-0004
Address
hukuura3-9,kanazawaku,yokohamashi
TEL
0457872547
Homepage URL
t236702e@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
YAMAJI FUMIKO NURSING RESEARCH FUND
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University
Address
3-9hukuura, kanazawaku,yokohamashi
Tel
0457872547
t236702e@yokohama-cu.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 | 09 | Month | 05 | 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
16
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
| 2024 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061709
