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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029425
Receipt No. R000033625
Scientific Title Feasibility Study of pelvic floor muscle training by midwife with internal vaginal examination after vaginal delivery.
Date of disclosure of the study information 2017/10/04
Last modified on 2018/04/17

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Basic information
Public title Feasibility Study of pelvic floor muscle training by midwife with internal vaginal examination after vaginal delivery.
Acronym Feasibility Study of pelvic floor muscle training with internal vaginal examination.
Scientific Title Feasibility Study of pelvic floor muscle training by midwife with internal vaginal examination after vaginal delivery.
Scientific Title:Acronym Feasibility Study of pelvic floor muscle training with internal vaginal examination.
Region
Japan

Condition
Condition Women after delivery
Midwife
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The object of this study is to verify the feasibility of pelvic floor muscle training with internal vaginal examination for both care providers and care recipients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Reliability and validity of intervention
Key secondary outcomes 1.Motivation for participation in research
2.Reaction of pelvic floor muscle training by internal vaginal examination
3.Urinary incontinence

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 Treatment
Type of intervention
Maneuver Other
Interventions/Control_1 Pelvic floor muscle training with internal vaginal examination.
Once on 4th day after birth.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Care provider
1.Midwife with more than 100 cases of childbirth assistance
Care recipient
1. Vaginal postpartum women
2.Mother and neonate both have good progress
3.Japanese
4.More than 20years old
5.The presence or absence of urinary incontinence is not required.
6.Primipara and multipara are included.
Key exclusion criteria Postpartum women who are expected to have difficulty in pelvic floor muscle training with internal vaginal examination such as large perineal laceration or strong pain.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akiko Mori
Organization St. Luke's International University
Division name Division of Women's Health and Midwifery
Zip code
Address 10-1, Akashi-cho, Chuo-ku, Tokyo, 104-0044, Japan
TEL 03-3543-6391
Email akiko-mori@slcn.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mayumi Ikeda
Organization St. Luke's International University, Postgraduate School
Division name Nursing science, Women's Health and Midwifery
Zip code
Address 10-1, Akashi-cho, Chuo-ku, Tokyo, 104-0044, Japan
TEL 03-3543-6391
Homepage URL
Email 16dn003@slcn.ac.jp

Sponsor
Institute St. Luke's International University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 10 Month 04 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 Completed
Date of protocol fixation
2017 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 09 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
2017 Year 10 Month 04 Day
Last modified on
2018 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033625

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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