UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034630 |
|---|---|
| Receipt number | R000039432 |
| Scientific Title | Pilot study for the effect of indirect perineal massage using towel for the prevention of perineal laceration before vaginal delivery |
| Date of disclosure of the study information | 2018/10/24 |
| Last modified on | 2019/05/20 16:52:48 |
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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
| Obstetrics 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
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
eidehara@juntendo.ac.jp
Public contact
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
eidehara@juntendo.ac.jp
Sponsor or person
Institute
Juntendo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039432
