Condition category
Pregnancy and Childbirth
Date applied
02/04/2008
Date assigned
30/04/2008
Last edited
14/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Andalusian Regional Ministry of Health (Spain)

Sponsor details

Avda de la Innovación s/n
Edif. Arena 1
Sevilla
41020
Spain

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23249535

Publication citations

  1. 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.

Additional files

Editorial Notes