UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029425 |
|---|---|
| Receipt number | 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 11:28:08 |
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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
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
16dn003@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033625
