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Moxibustion for Fetus in Breech Presentation

Primary Purpose

Breech Presentation

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Moxibustion of the BL67 acupoint
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breech Presentation focused on measuring Breech presentation at 34 to 36 weeks of gestation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Breech presentation
  • 34 to 36 weeks of gestation
  • Single fetus

Exclusion Criteria:

  • Uterine malformation
  • Placenta praevia
  • Transverse lie

Sites / Locations

  • Hôpitaux Universitaires de Genève

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Moxibustion

Control

Arm Description

Outcomes

Primary Outcome Measures

Cephalic presentation at delivery or before external cephalic version

Secondary Outcome Measures

Mode of delivery
Women's views on the intervention
External cephalic version

Full Information

First Posted
April 28, 2009
Last Updated
April 28, 2009
Sponsor
University Hospital, Geneva
Collaborators
Swiss National Science Foundation, Loterie Romande
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1. Study Identification

Unique Protocol Identification Number
NCT00890474
Brief Title
Moxibustion for Fetus in Breech Presentation
Official Title
Moxibustion for Fetus in Breech Presentation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Geneva
Collaborators
Swiss National Science Foundation, Loterie Romande

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Presentation
Keywords
Breech presentation at 34 to 36 weeks of gestation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moxibustion
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Moxibustion of the BL67 acupoint
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cephalic presentation at delivery or before external cephalic version
Time Frame
end of pregnancy
Secondary Outcome Measure Information:
Title
Mode of delivery
Time Frame
end of pregnancy
Title
Women's views on the intervention
Time Frame
end of pregnancy
Title
External cephalic version
Time Frame
end of pregnancy

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Breech presentation 34 to 36 weeks of gestation Single fetus Exclusion Criteria: Uterine malformation Placenta praevia Transverse lie
Facility Information:
Facility Name
Hôpitaux Universitaires de Genève
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20168104
Citation
Guittier MJ, Pichon M, Dong H, Irion O, Boulvain M. Moxibustion for breech version: a randomized controlled trial. Obstet Gynecol. 2009 Nov;114(5):1034-1040. doi: 10.1097/AOG.0b013e3181bc707a.
Results Reference
derived

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Moxibustion for Fetus in Breech Presentation

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