UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Self-administered Smoke or Smokeless Moxibustion on Breech Presentation Converting to Cephalic Presentation
Title of the study (Brief title)	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	Akiko Higashihara
Organization	St. Luke's International University Graduate School
Division name	Science in nursing, Women's Health & Midwifery
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	Akiko Higashihara
Organization	St.Luke's International University Graduate School
Division name	Science in nursing, Women's Health & Midwifery
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000024654