UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021377 |
|---|---|
| Receipt number | R000024654 |
| Scientific Title | Effect of Self-administered Smoke or Smokeless Moxibustion on Breech Presentation Converting to Cephalic Presentation |
| Date of disclosure of the study information | 2016/03/07 |
| Last modified on | 2017/03/30 15:57:26 |
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Basic information
Public title
Effect of Self-administered Smoke or Smokeless Moxibustion on Breech Presentation Converting to Cephalic Presentation
Acronym
Smoke or Smokeless Moxibustion for Breech Presentation: A quasi-experimental study
Scientific Title
Effect of Self-administered Smoke or Smokeless Moxibustion on Breech Presentation Converting to Cephalic Presentation
Scientific Title:Acronym
Smoke or Smokeless Moxibustion for Breech Presentation: A quasi-experimental study
Region
| Japan |
Condition
Condition
Pregnant women with a singleton breech presentation between 33 and 35 weeks of gestation
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of using smoke moxibustion and smokeless moxibustion with the usual care alone on the conversion into cephalic presentation, and assess their effects on the well-being of women and child, as well as verify the feasibility of the study protocol.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Cephalic presentations at two weeks after the start of interventions.
Key secondary outcomes
(1) Cephalic presentations at birth (excluding external cephalic version)
(2) Birthing outcomes (the mode of birth, premature birth requiring hospitalization, preterm birth, pre-labor rupture of membranes at < 37 weeks, gestational age at birth, Apgar score < 7 at 5 min., birthweight, admission to NICU, cord blood pH less than 7.1, perinatal morbidity and mortality,
(3) The number of self-reported fetal movements.
(4) Side effects from using moxa sticks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Interventions : A
To stimulate the acupoint BL67 by moxibustion (smoke moxa sticks ) for 20 minutes each time, once or twice daily for 10-14 days
Interventions/Control_2
Interventions : B
To stimulate the acupoint BL67 by moxibustion (smokeless moxa sticks ) for 20 minutes each time, once or twice daily for 10-14 days
Interventions/Control_3
Usual care
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 33 and 35 weeks of gestation.
2.Normal fetal biometry, and normal pregnancy progress
3.Japanese women aged greater than 18 years.
Key exclusion criteria
1.Pregnancy with multiples beyond twins, risk of preterm birth (preterm uterine contractions and/or initial dilatation or shortening of the cervix with a score of 4 on the Bishop scale, tocolytic therapy), uterine fibroids > 4cm, maternal heart or kidney disease, placenta previa, complications with pregnancy-induced hypertension, pre-labor rupture of the membranes, contraindication to vaginal delivery, intrauterine growth restriction, fetal malformation or chromosomal disorder, pregnant woman or siblings of the fetus diagnosed with bronchial asthma or a pulmonary problem, and is treated (only in the intervention group)
2.previous uterine surgery, uterine malformations, bone pelvic defects, allergies of Artemisia vulgaris (only in the intervention group), pregnant woman or siblings of the fetus who have symptoms of coughing, respiratory discomfort by smoke (only in the intervention group)
3.prior treatment with moxibustion to achieve version of the fetus
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiko Higashihara |
Organization
St. Luke's International University Graduate School
Division name
Science in nursing, Women's Health & Midwifery
Zip code
Address
3-8-5, Tsukiji, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL
03-6226-6361
14dn012@slcn.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Higashihara |
Organization
St.Luke's International University Graduate School
Division name
Science in nursing, Women's Health & Midwifery
Zip code
Address
3-8-5, Tsukiji, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL
03-6226-6361
Homepage URL
14dn012@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
YAMAJI FUMIKO grant in aid for Nursing research
Japan Academy of Midwifery grant in aid for encouragement research
IRB Contact (For public release)
Organization
Address
Tel
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
聖路加国際病院 St. Luke's International Hospital（東京都）
他
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 07 | 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
| 2016 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 07 | Day |
Last modified on
| 2017 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024654
