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CompletedNCT00890474Updated Apr 29, 2009

Moxibustion for Fetus in Breech Presentation

A Phase 3 interventional study of Moxibustion of the BL67 acupoint in Breech Presentation, sponsored by University Hospital, Geneva. Completed at 1 site in Switzerland. Open to female participants. Per ClinicalTrials.gov, last updated 2009-04-29.

Sponsored by University Hospital, Geneva · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
212
Allocation
Randomized
Sex
Female
01

Study 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.

02

Conditions studied

  • Breech Presentation

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Keywords

  • Breech presentation at 34 to 36 weeks of gestation
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Uterine malformation
  • Placenta praevia
  • Transverse lie
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
212 participants (actual)

Study arms

  • Experimental
    Moxibustion

    Procedure: Moxibustion of the BL67 acupoint

  • No intervention
    Control

Interventions

  • ProcedureMoxibustion 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.

05

What researchers measure

Primary outcomes

  1. Cephalic presentation at delivery or before external cephalic version

    Time frame: end of pregnancy

Secondary outcomes

  1. Mode of delivery

    Time frame: end of pregnancy

  2. Women's views on the intervention

    Time frame: end of pregnancy

  3. External cephalic version

    Time frame: end of pregnancy

06

Study locations

1 site
  • Hôpitaux Universitaires de Genève
    Geneva, Switzerland
07

References and documents

Publications

  • 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. PubMed 20168104 ↗
08

Registry details

Key details

Study ID
NCT00890474
Lead sponsor
University Hospital, Geneva
Collaborators
Swiss National Science Foundation, Loterie Romande
First posted
Apr 29, 2009
Start date
Oct 2004
Primary completion
Dec 2008
Completion
Jan 2009
Last update
Apr 29, 2009

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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