Moxibustion for Fetus in Breech Presentation

Breech Presentation Clinical Trial

Official title:

Moxibustion for Fetus in Breech Presentation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890474
• Other study ID #: Moxibustion_siege
• Status: Completed
• Phase: Phase 3
• First received: April 28, 2009
• Last updated: April 28, 2009
• Start date: October 2004
• Est. completion date: January 2009

Study information

• Verified date: April 2009
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Objective: To evaluate moxibustion of the BL67 acupoint between 34 and 38 weeks of gestation to facilitate cephalic version of breech presentation in a Western setting. The hypothesis is that moxibustion increase the likelihood of cephalic version.

Design: Randomised controlled trial Setting: University hospital. Population: A total of 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation will be randomised to moxibustion (n=106) or expectant management (n=106).

Main Outcome Measure: Cephalic presentation at delivery or before external cephalic version.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Breech presentation

• 34 to 36 weeks of gestation

• Single fetus

Exclusion Criteria:

• Uterine malformation

• Placenta praevia

• Transverse lie

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breech Presentation

Intervention

Procedure:
• Moxibustion of the BL67 acupoint
Moxibustion sessions every day (every other day in hospital, self-administration at home the other day) during a maximum of 14 days. Stopped if cephalic version.

Locations

Country	Name	City	State
Switzerland	Hôpitaux Universitaires de Genève	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Geneva	Loterie Romande, Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cephalic presentation at delivery or before external cephalic version		end of pregnancy	No
Secondary	Mode of delivery		end of pregnancy	No
Secondary	Women's views on the intervention		end of pregnancy	No
Secondary	External cephalic version		end of pregnancy	No