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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032304
Receipt No. R000036820
Scientific Title Comparison of instructional methods by digital vaginal palpation and transabdominal ultrasound in pelvic floor muscle training after vaginal delivery: A randomized controlled trial
Date of disclosure of the study information 2018/07/01
Last modified on 2019/10/22

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Basic information
Public title Comparison of instructional methods by digital vaginal palpation and transabdominal ultrasound in pelvic floor muscle training after vaginal delivery: A randomized controlled trial
Acronym PFMT by digital vaginal palpation and transabdominal ultrasound
Scientific Title Comparison of instructional methods by digital vaginal palpation and transabdominal ultrasound in pelvic floor muscle training after vaginal delivery: A randomized controlled trial
Scientific Title:Acronym PFMT by digital vaginal palpation and transabdominal ultrasound
Region
Japan

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

Objectives
Narrative objectives1 To compare the effect of digital vaginal palpation and transabdominal ultrasound in pelvic floor muscle training instruction method for low-risk women after vaginal delivery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bladder base movement during voluntary pelvic floor muscle contraction by Transabdominal ultrasound
Key secondary outcomes 1. Fast repetition
2. Endurance
3. Understanding the contraction muscle/Contraction feeling
4. Confidence for pelvic floor muscle training
5. Motivation for pelvic floor muscle training

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Pelvic floor muscle training by digital vaginal palpation
Interventions/Control_2 Pelvic floor muscle training by transabdominal ultrasound
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 Women 4-6weeks after vaginal delivery of 37 or more weeks
Key exclusion criteria 1.Experience of pelvic floor muscle training using digital vaginal palpation or transabdominal ultrasound
2.Abnormality in postpartum process
3.Pain and numbness of the perineum
4.Neuropathic urinary incontinence
5.Age under 20 years old
6.Unable read or write in Japanese

Target sample size 60

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

Public contact
Name of contact person
1st name Mayumi
Middle name
Last name Ikeda
Organization St.Luke's International University Graduate school
Division name Doctoral student
Zip code 104-0044
Address 10-1,Akashi-cho,Chuo-ku,Tokyo, Japan
TEL 03-3543-6391
Homepage URL
Email 16DN003@slcn.ac.jp

Sponsor
Institute St.Luke's International University
Institute
Department

Funding Source
Organization Japan Health Academy
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 St.Luke's International University
Address 10-1,Akashi-cho,Chuo-ku,Tokyo,Japan
Tel 03-3543-6391
Email 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

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 01 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
2018 Year 04 Month 12 Day
Date of IRB
2018 Year 06 Month 14 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 18 Day
Last modified on
2019 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036820

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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