UMIN-CTR Clinical Trial

Basic information
Public title	Pilot study for the effect of indirect perineal massage using towel for the prevention of perineal laceration before vaginal delivery
Acronym	The effect of indirect perineal massage for the prevention of perineal laceration.
Scientific Title	Pilot study for the effect of indirect perineal massage using towel for the prevention of perineal laceration before vaginal delivery
Scientific Title:Acronym	The effect of indirect perineal massage for the prevention of perineal laceration.
Region	Japan

Condition
Condition	perineal laceration
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of indirect perineal massage for prevention of perineal laceration.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of 2nd degrees perineal laceration.
Key secondary outcomes	Continues rate of indirect perineal massage

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Pregnant women scheduled for vaginal delivery at Juntendo Hospital will be obtain to this study. Informed consent will be obtained at the midwife outpatient clinic from 35 weeks to 36 weeks gestation,and will be instructe indirect perineal massage. (Method of indirect perineal massage: Make a towel in a roll shape, adjust the size to the extent that there is no pain when the towel adjusted to the perineum.Make the roll towels to fit the perineum at the sitting position.Shake the body to the right and left for about 5 minutes). With pregnancy 37 week 0 as the start date, pregnant women will do as they want. Regarding the evaluation on perineal massage,a questionnaire created based on "Japanese version of Opinion of women after childbirth to perineal massage during pregnancy" developed by Takeuchi et al. (2014) "will be used. The questionnaire will be handed and recovered at postpartum. during postpartum hospitalization Distribute and collect.
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	50 years-old >
Gender	Female
Key inclusion criteria	A pregnant woman at the 35 to 36 weeks of pregnancy who will see a midwife outpatient clinic from the approval date to November 30, 2018.
Key exclusion criteria	1,Cesarean section case. 2,Pregnant women with lesions in the perineal area (varicose veins, condyloma acuminata, herpes etc.). 3,Other who judged that the research director is inappropriate as the research subject.
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Emiko Middle name Last name Idehara
Organization	Juntendo Hospital
Division name	Department of nursing
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	0338133111
Email	eidehara@juntendo.ac.jp

Public contact
1st name of contact person	1st name Emiko Middle name Last name Idehara
Organization	Juntendo Hospital
Division name	Department of nursing
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	eidehara@juntendo.ac.jp

Sponsor
Institute	Juntendo Hospital
Institute
Department

Funding Source
Organization	Juntendo Hospital
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	Ethics Committee of Juntendo Hospital
Address	3-1-3Hongo, Bunkyo-ku, Tokyo
Tel	03-3814-5672
Email	kenkyu5858@juntendo.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	順天堂大学医学部附属順天堂医院

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 24 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	139
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	Main results already published
Date of protocol fixation	2018 Year 09 Month 12 Day
Date of IRB	2018 Year 09 Month 18 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2018 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 24 Day
Last modified on	2019 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039432