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Moxibustion for Fetus in Breech Presentation

This study has been completed.
Sponsor:
Collaborators:
Swiss National Science Foundation
Loterie Romande
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00890474
First received: April 28, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Breech Presentation
 Procedure: Moxibustion of the BL67 acupoint
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Moxibustion for Fetus in Breech Presentation

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Cephalic presentation at delivery or before external cephalic version [ Time Frame: end of pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mode of delivery [ Time Frame: end of pregnancy ] [ Designated as safety issue: No ]
  • Women's views on the intervention [ Time Frame: end of pregnancy ] [ Designated as safety issue: No ]
  • External cephalic version [ Time Frame: end of pregnancy ] [ Designated as safety issue: No ]

Enrollment: 212
Study Start Date: October 2004
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moxibustion 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.
No Intervention: Control

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Uterine malformation
  • Placenta praevia
  • Transverse lie
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890474

Locations
Switzerland
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Sponsors and Collaborators
University Hospital, Geneva
Swiss National Science Foundation
Loterie Romande
  More Information

No publications provided by University Hospital, Geneva

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marie-Julia Guittier, Hôpitaux Universitaires de Genève
ClinicalTrials.gov Identifier: NCT00890474     History of Changes
Other Study ID Numbers: Moxibustion_siege
Study First Received: April 28, 2009
Last Updated: April 28, 2009
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
Breech presentation at 34 to 36 weeks of gestation

Additional relevant MeSH terms:
Breech Presentation
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on June 17, 2013