Breech Presentation Clinical Trial
Official title:
Moxibustion for Fetus in Breech Presentation
Verified date | April 2009 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Hôpitaux Universitaires de Genève | Geneva |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva | Loterie Romande, Swiss National Science Foundation |
Switzerland,
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 |
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