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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017167
Receipt No. 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

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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
Obsterics 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
Last 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
Email 13DN006-ts@slcn.ac.jp

Public contact
1st 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
Email 13DN006-ts@slcn.ac.jp

Sponsor
Institute St.Luke's International University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019914

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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