Correcting non cephalic presentation with moxibustion: Study protocol for a multi-centre randomised controlled trial in general practice
| ISRCTN | ISRCTN10634508 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10634508 |
| Secondary identifying numbers | 0053/2007 |
- Submission date
- 02/04/2008
- Registration date
- 30/04/2008
- Last edited
- 14/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jorge Vas
Scientific
Scientific
Centro de Salud
Unidad de Tratamiento del Dolor
C/ Segovia s/n
Dos Hermanas
41700
Spain
| jorgef.vas.sspa@juntadeandalucia.es |
Study information
| Study design | Multi-centre randomised controlled trial with three parallel arms. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | Clinical Trials Ethics Committee of the Andalusian Regional Government. Date of approval: 26/02/2008 (ref: acta 02/08) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2008 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 492 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2008 |
| Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- Spain
Study participating centre
Centro de Salud
Dos Hermanas
41700
Spain
41700
Spain
Sponsor information
Andalusian Regional Ministry of Health (Spain)
Government
Government
Avda de la Innovación s/n
Edif. Arena 1
Sevilla
41020
Spain
"ROR" |
https://ror.org/03q4c3e69 |
|---|
Funders
Funder type
Government
Andalusian Regional Ministry of Health (Project No. 0053/2007)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2013 | Yes | No |
