Contact information
Type
Scientific
Primary contact
Dr Jorge Vas
ORCID ID
Contact details
Centro de Salud
Unidad de Tratamiento del Dolor
C/ Segovia s/n
Dos Hermanas
41700
Spain
jorgef.vas.sspa@juntadeandalucia.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0053/2007
Study information
Scientific title
Acronym
Study hypothesis
A sensorial stimulation with moxibustion in the outer corner of the little toenail (BL67) produce a greater proportion of version in non-cephalic presentations than the usual care.
Ethics approval
Clinical Trials Ethics Committee of the Andalusian Regional Government. Date of approval: 26/02/2008 (ref: acta 02/08)
Study design
Multi-centre randomised controlled trial with three parallel arms.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Non cephalic presentation of fetus
Intervention
All the study subjects will be given various postural recommendations.
The participants will be randomly allocated to the following three arms:
Arm A: True moxibustion (TM): The first intervention will be made at the Healthcare Clinic. This session (overseen by the responsible midwife) will serve as a training session for the friend or relative who is to apply the remaining sessions at home. The mother should lie down, face up, wearing comfortable clothing and with no pressure at the waist from buttons, belt, etc. and with her legs slightly bent at the knee. Heat will be applied for 20 minutes, by means of a moxa cone (a herbal preparation with Artemisia vulgaris) at point BL67 (Zhiyin), close to the outer angle of the little toenail. The heat will be applied from a distance of 1.5-3 cm, to ensure that the subject notices a feeling of warmth in the zone, but without any pain or burning. The application site (right or left foot) will be alternated every 2 minutes, or more often if any untoward sensation of heat is felt. True moxibustion will be carried out once a day for two weeks, or until cephalic version occurs.
Arm B: False/sham moxibustion (SM): This procedure will be identical to that applied to the TM group except that the point stimulated will be a non-active one according to the principles of Traditional Chinese Medicine, point SP1 (Yinbai), close to the inner angle of the big toenail. False moxibustion will be carried out once a day for two weeks, or until cephalic version occurs.
Arm C: Control group, under observation (CG): The subjects in this group will receive the standard treatment, in accordance with the Andalusian Healthcare System Treatment Guide.
Intervention type
Drug
Phase
Not Specified
Drug names
Moxibustion
Primary outcome measure
Rate of cephalic presentation at term.
Secondary outcome measures
1. Rate of cephalic presentation at week 38 of gestation (CP38), determined by echography
2. Number of days of treatment received until version occurs
3. Rate of caesarean sections
4. Security variables:
4.1. Increased rates of foetal cardiac rhythm change, followed-up until birth
4.2. Risk of premature birth
4.3. Changes in Apgar scores at 1 minute and at 5 minutes 1. Rate of cephalic presentation at week 38 of gestation (CP38), determined by echography
2. Number of days of treatment received until version occurs
3. Rate of caesarean sections
4. Security variables:
4.1. Increased rates of foetal cardiac rhythm change
4.2. Risk of premature birth
4.3. Changes in Apgar scores at 1 minute and at 5 minutes
Overall trial start date
01/04/2008
Overall trial end date
01/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Pregnant women
2. Aged at least 18 years
3. Foetus is in a non cephalic position (diagnosed by physical examination and by echography)
4. Gestational age of 33-35 weeks (estimated by echography)
5. Normal foetal biometry
6. Those who have signed their informed consent
7. Have not previously received moxibustion treatment to correct the position of their unborn baby
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
492
Participant exclusion criteria
1. Twin pregnancy
2. Pelvic defect
3. Previous uterine surgery
4. Foetal malformation or chromosome disorder
5. Uterine malformation
6. Risk of premature birth (preterm uterine contractions and/or initial dilation or shortening of the cervix with a Bishop's score of 4)
7. Uterine fibromas >4 cm
8. Treatment with tocolytic drugs
9. Heart or kidney disease affecting the mother
10. Other pregnancy-related complications
11. Inability to complete the questionnaire or respond to the assessor's questions
Recruitment start date
01/04/2008
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Spain
Trial participating centre
Centro de Salud
Dos Hermanas
41700
Spain
Funders
Funder type
Government
Funder name
Andalusian Regional Ministry of Health (Project No. 0053/2007)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23249535
Publication citations
-
Results
Vas J, Aranda-Regules JM, Modesto M, Ramos-Monserrat M, Barón M, Aguilar I, Benítez-Parejo N, Ramírez-Carmona C, Rivas-Ruiz F, Using moxibustion in primary healthcare to correct non-vertex presentation: a multicentre randomised controlled trial., Acupunct Med, 2013, 31, 1, 31-38, doi: 10.1136/acupmed-2012-010261.