UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017167 |
|---|---|
| Receipt number | R000019914 |
| Scientific Title | Effects of a Simulation Training Program for Midwives to Manage Postpartum Hemorrhage: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2015/04/18 |
| Last modified on | 2015/04/18 11:34:28 |
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Basic information
Public title
Effects of a Simulation Training Program for Midwives to Manage Postpartum Hemorrhage: A Randomized Controlled Trial
Acronym
Effects of a Simulation Training Program for Midwives to Manage Postpartum Hemorrhage: A Randomized Controlled Trial
Scientific Title
Effects of a Simulation Training Program for Midwives to Manage Postpartum Hemorrhage: A Randomized Controlled Trial
Scientific Title:Acronym
Effects of a Simulation Training Program for Midwives to Manage Postpartum Hemorrhage: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Postpartum hemorrhage
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of simulation training program for midwives to manage postpartum hemorrhage on performance and knowledge.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
performance
Key secondary outcomes
knowledge
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Simulation training program to manage postpartum hemorrhage
Interventions/Control_2
No training
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
They have 2 or 3 years clinical experience for midwife
Midwives working in the Obstetric
department
They have a experience for birth
assistance
Key exclusion criteria
They have an experience of simulation training to manage postpartum hemorrhage
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chiho KATO |
Organization
St.Luke's International University
Division name
Graduate school of Nursing
Zip code
Address
3-8-5, Tsukiji, Chuo-ku, Tokyo
TEL
03-6226-6361
13DN006-ts@slcn.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiho KATO |
Organization
St.Luke's International University
Division name
Graduate school of Nursing
Zip code
Address
3-8-5, Tsukiji, Chuo-ku, Tokyo
TEL
03-6226-6361
Homepage URL
13DN006-ts@slcn.ac.jp
Sponsor or person
Institute
St.Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Fumiko Yamaji grant in aid for Nursing research
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
Address
Tel
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
| 2015 | Year | 04 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 18 | Day |
Last modified on
| 2015 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019914
