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Moxibustion for Fetus in Breech Presentation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00890474
First Posted: April 29, 2009
Last Update Posted: April 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Swiss National Science Foundation
Loterie Romande
Information provided by:
University Hospital, Geneva
  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
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
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 ]

Secondary Outcome Measures:
  • Mode of delivery [ Time Frame: end of pregnancy ]
  • Women's views on the intervention [ Time Frame: end of pregnancy ]
  • External cephalic version [ Time Frame: end of pregnancy ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890474


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

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
First Submitted: April 28, 2009
First Posted: April 29, 2009
Last Update Posted: April 29, 2009
Last Verified: April 2009

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