UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046134 |
|---|---|
| Receipt number | 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 | 2025/03/31 19:48:43 |
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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
| Obstetrics 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, once or twice daily for 10-14 days (to be conducted at least 20 times during the period).
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
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
higashihara-akiko@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
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
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
17
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
| 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
| 2024 | 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
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052660
