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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046134
Receipt No. R000052660
Scientific Title Verification of the feasibility of smokeless moxibustion performed at home by women with breech presentation: Introduction of the method using ICT
Date of disclosure of the study information 2021/11/21
Last modified on 2021/11/21

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Basic information
Public title A feasibility study of smokeless moxibustion for pregnant women in breech presentation at home: Using online
Acronym Feasibility of moxibustion at home for breech presentation
Scientific Title Verification of the feasibility of smokeless moxibustion performed at home by women with breech presentation: Introduction of the method using ICT
Scientific Title:Acronym Feasibility of smokeless moxibustion performed at home for breech presentation: Using online
Region
Japan

Condition
Condition Pregnant women with a singleton breech presentation between 32 and 35 weeks of gestation.
Classification by specialty
Obsterics and gynecology Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the feasibility if women with breech presentation could be perform moxibustion by themselves at home following the intervention protocol by the method of using a web conference tool and video.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Feasibility
Implementation
1.Number of women who were able to implement the protocol as per the protocol.
2.Number of days and number of times each moxibustion could be performed according to the protocol.
Key secondary outcomes Practicality
1.Side effects of intervention.
Feelings of unpleasantness, nausea, vomiting, uterine contraction, burns, and levels with burns.
2.How pregnant women feel about the "smell" of moxibustion.
3.Burden of implementing moxibustion
4.Changes in physical symptoms after the implementation of moxibustion

Acceptability
1.satisfaction
2.Families' understanding of moxibustion implementation.
3.Evaluation of explanation methods, materials used, and explanations using a web conference tool.

Obstetric-gynecological variables
(parity, gestational age at the start of treatment, height (cm), weight (kg), employment status, and sensitivity to cold, fetal presentation after 10-14 days from commencement of the intervention)


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
Other
Interventions/Control_1 To stimulate the acupoint BL67 by moxibustion (smokeless moxa sticks ) for 20 minutes (10 minutes on each side) each time, twice daily for 10-14 days.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1.Pregnant women with a singleton breech presentation between 32 and 35 gestation weeks.
2.Japanese women aged 18 years and above, with normal fetal biometry, and with normal progression of pregnancy.
Key exclusion criteria 1.Complications: maternal heart or kidney disease.
2.Obstetric complications: pregnancy with multiples of twins and beyond, risk of preterm birth (preterm uterine contractions, initial dilatation, or shortening of the cervix with a score of 4 on the Bishop scale; tocolytic therapy), uterine fibroids > 4 cm, placenta previa, hypertensive disorders of pregnancy, premature rupture of membranes.
3.Contraindication to vaginal delivery: previous uterine surgery, uterine malformations, bone pelvic defects.
4.Fetal conditions: intrauterine growth restriction, fetal malformation, or chromosomal disorder.
5.Conditions to avoid in interventions: prior moxibustion treatment to achieve fetal version.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Akiko
Middle name
Last name Higashihara
Organization Saitama Prefectural University
Division name Department of Nursing
Zip code 343-8540
Address 820 Sannomiya, Koshigaya-shi, Saitama 343-8540, Japan
TEL 0489734175
Email higashihara-akiko@spu.ac.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Higashihara
Organization Saitama Prefectural University
Division name Department of Nursing
Zip code 343-8540
Address 820 Sannomiya, Koshigaya-shi, Saitama 343-8540, Japan
TEL 0489734175
Homepage URL
Email higashihara-akiko@spu.ac.jp

Sponsor
Institute Saitama Prefectural University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science (JSPS) KAKENHI
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Screening Committee of the Institutional Review Board of Saitama Prefectural University
Address 820 Sannomiya, Koshigaya-shi, Saitama 343-8540, Japan
Tel 048-973-4120
Email rinri@spu.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

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 21 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 Preinitiation
Date of protocol fixation
2021 Year 11 Month 21 Day
Date of IRB
2021 Year 08 Month 23 Day
Anticipated trial start date
2021 Year 11 Month 21 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 21 Day
Last modified on
2021 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052660

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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