UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility Study of pelvic floor muscle training by midwife with internal vaginal examination after vaginal delivery.
Title of the study (Brief title)	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	Akiko Mori
Organization	St. Luke's International University
Division name	Division of Women's Health and Midwifery
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	Mayumi Ikeda
Organization	St. Luke's International University, Postgraduate School
Division name	Nursing science, Women's Health and Midwifery
Address	10-1, Akashi-cho, Chuo-ku, Tokyo, 104-0044, Japan
TEL	03-3543-6391
Homepage URL
Email	16dn003@slcn.ac.jp

Sponsor
Institute	St. Luke's International University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033625