UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032304 |
|---|---|
| Receipt number | 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 16:25:32 |
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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
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
16DN003@slcn.ac.jp
Sponsor or person
Institute
St.Luke's International University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036820
