UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026188
Receipt number 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 18:32:53

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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

Obstetrics 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 or person

Institute

University of Yamanashi

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029278


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name