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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021377
Receipt No. 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

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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
Obsterics 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
Email 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
Email 14dn012@slcn.ac.jp

Sponsor
Institute St. Luke's International University
Institute
Department

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
Email

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)

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024654

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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