UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026188
Receipt No. R000029278
Scientific Title Effect of "educational and practical program about pelvic floor muscle training for women between 36 gestational weeks and 5 months postpartum" to reduce the size of levator hiatus
Date of disclosure of the study information 2017/02/17
Last modified on 2020/06/19 (Ver. 6)

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Basic information
Public title Effect of "educational and practical program about pelvic floor muscle training for women between 36 gestational weeks and 5 months postpartum" to reduce the size of levator hiatus
Acronym Examination about recovery of pelvic floor after delivery -efficacy of pelvic floor muscle training-
Scientific Title Effect of "educational and practical program about pelvic floor muscle training for women between 36 gestational weeks and 5 months postpartum" to reduce the size of levator hiatus
Scientific Title:Acronym Examination about recovery of pelvic floor after delivery -efficacy of pelvic floor muscle training-
Region
Japan

Condition
Condition Pregnant women and women after delivery
Classification by specialty
Obsterics and gynecology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The object of this study is to clarify the effectiveness of "educational and practical program about pelvic floor muscle training for women between 36 gestational weeks and 5 months postpartum" to reduce the size of levator hiatus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of levator ani muscle using ultrasounds
Key secondary outcomes 1.Questionnaires(about pelvic organ prolapse, lower urinary tract symptoms and other symptoms)
2.Evaluations by internal vaginal examination

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Intervention group;
intervention program("educational and practical program about pelvic floor muscle training for women between 36 gestational weeks and 5 months postpartum")
Interventions/Control_2 Comparison group;
usual care
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 1.singleton pregnancy
2.outpatients at 3rd trimester
(gestational age between about 30 and 36 weeks)
3.age>=20
4.ability to understand Japanese
5.written informed consent
Key exclusion criteria 1.women with neuropathic urinary incontinence
2.women who cannot contract pelvic floor muscle correctly at 1 month postpartum
3.women who are difficult to follow until 5 months postpartum
4.women who are judged to be inappropriate by investigator
(maternal complications, abnormal fetus, and other reason)

Target sample size 90

Research contact person
Name of lead principal investigator
1st name Yasue
Middle name
Last name Kobayashi
Organization University of Yamanashi
Division name Graduate Faculty of Interdisciplinary Research
Zip code 409-3898
Address 1110 Shimokato, Chuo City, Yamanashi Pref, 409-3898, Japan
TEL 055-273-8614
Email yasue@yamanashi.ac.jp

Public contact
Name of contact person
1st name Satoko
Middle name
Last name Takaoka
Organization University of Yamanashi
Division name Division of Nursing and Health Science, Graduate School of Medicine and Engineering
Zip code 409-3898
Address 1110 Shimokato, Chuo City, Yamanashi Pref, 409-3898, Japan
TEL 055-273-1111(ext.2755)
Homepage URL
Email takaoka-stk@umin.ac.jp

Sponsor
Institute University of Yamanashi
Institute
Department

Funding Source
Organization YAMAJI FUMIKO nursing research fund
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Mediarea Support

IRB Contact (For public release)
Organization The Research Ethics Committee of Faculty of Medicine, University of Yamanashi
Address 1110 Shimokato, Chuo City, Yamanashi Pref, 409-3898, Japan
Tel 055-273-9065
Email rec-med@yamanashi.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
2017 Year 02 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 92
Results 
44 women in the intervention group and 45 in the comparison one were analyzed. There were 36 women who reached a high adherence to three daily sets of pelvic floor muscle training in the intervention group. The reduction in the levator hiatus area at rest was not statistically higher in the intervention group than that in the comparison one. However, for the subgroup with high adherence, the reduction in the area was significantly higher by 4.43% in the intervention group than that in the comparison group.
Results date posted
2020 Year 06 Month 19 Day
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 Main results already published
Date of protocol fixation
2017 Year 02 Month 15 Day
Date of IRB
2016 Year 11 Month 09 Day
Anticipated trial start date
2017 Year 02 Month 20 Day
Last follow-up date
2018 Year 06 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 17 Day
Last modified on
2020 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029278