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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026699
Receipt No. R000030311
Scientific Title Cephalic version by appliance for acupuncture of the moxa cautery for breech presentation
Date of disclosure of the study information 2017/04/01
Last modified on 2019/03/31

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Basic information
Public title Cephalic version by appliance for acupuncture of the moxa cautery for breech presentation
Acronym The breech presentation correction
Scientific Title Cephalic version by appliance for acupuncture of the moxa cautery for breech presentation
Scientific Title:Acronym The breech presentation correction
Region
Japan

Condition
Condition Breech presentation
Classification by specialty
Obsterics and gynecology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A purpose of this study is to see an effect of the breech correction due to the effective spot for applying moxa stimulation using a needle or the appliance for the moxibustion
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Evaluation of intervention initiation two weeks later and the intranatal presentation
Key secondary outcomes Minor trouble two weeks after the intervention start

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 ・Medical device name:A needle or appliance for the moxibustion(Brand name:Korisupoto)
・Intervention period:2 week
・Quantity of the intervention:By one piece attaches it on moxibustion of acupoint San Yin Jiao (Sp 6) and Zhiyin (BL 67),of both legs
・Frequency of the intervention:It is necessary to repaper it within 24 hours every day
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Breech pregnant woman of the pregnancy 30~31 week
Key exclusion criteria ・Pregnant woman of the early or threatened labour
・The pregnant woman who had a diagnosis of malposition of placenta
・Pregnant woman of the geminus
・Bleeding disorders merger pregnant woman
・Malignant tumor merger pregnant woman
・Contact dermatitis merger pregnant woman
・Pregnant woman with allergy
・The pregnant woman who plans delivery by the cesarean section for a reason except the breech presentation
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Minami
Middle name
Last name Miura
Organization Shiga University of Medical Science Hospital
Division name Nursing Department 6A
Zip code 520-2192
Address Tsukinowa,Seta,Otsu,Shiga,Japan
TEL 077-548-2674
Email mina620@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name Minami
Middle name
Last name Miura
Organization Shiga University of Medical Science Hospital
Division name Nursing Department 6A
Zip code 520-2192
Address Tsukinowa,Seta,Otsu,Shiga,Japan
TEL 077-548-2674
Homepage URL http://www.shiga-med.ac.jp/hospital/doc/ethics/kangobu/kangobu.html
Email mina620@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science Hospital
Institute
Department

Funding Source
Organization Not applicable
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Not applicable
Name of secondary funder(s) Not applicable

IRB Contact (For public release)
Organization Shiga University of Medical Science Hospital
Address Tsukinowa,Seta,Otsu,Shiga,Japan
Tel 0775482674
Email mina620@belle.shiga-med.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 滋賀医科大学医学部附属病院(滋賀県)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 01 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 06 Month 23 Day
Date of IRB
2017 Year 06 Month 23 Day
Anticipated trial start date
2017 Year 11 Month 08 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information Not applicable

Management information
Registered date
2017 Year 03 Month 25 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030311

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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