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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name