Cephalic Version by Acupuncture for Breech Presentation
Study of Cephalic Version by Acupuncture for Breech Presentation.
1 other identifier
interventional
259
1 country
1
Brief Summary
We want to study the efficiency of acupuncture for cephalic version of breech presentation during pregnancy. Several randomized studies show that acupuncture may be useful in version of breech presentation, but none with a sham. Protocol :
- Inclusion of patients with fetus in breech presentation at 32-34 weeks of pregnancy.
- Randomization. First group : acupuncture by stimulation of "67 Bladder" point.Second group : stimulation of "45 Stomach" point (sham).
- Ultrasonographic control of presentation at 35 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 22, 2008
CompletedFirst Posted
Study publicly available on registry
December 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedDecember 22, 2025
December 1, 2025
6.2 years
December 22, 2008
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cephalic or breech presentation (ultrasonographic control at 35 weeks of pregnancy)
35 weeks
Secondary Outcomes (1)
general outcomes about external cephalic version, delivery and neonates
35 weeks
Study Arms (2)
1
EXPERIMENTALStimulation of "67 Bladder" point
2
SHAM COMPARATORStimulation of "45 Stomach" point (sham)
Interventions
Eligibility Criteria
You may qualify if:
- Single pregnancy at 32-34 weeks of pregnancy.
- Fetus in breech presentation.
You may not qualify if:
- Twins.
- Story of preterm birth or any preterm birth risk
- Fetal malformations, abnormal karyotype
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Gynécologie-Obstétrique, Hôpital SIHCUS - CMCO, 19 rue Louis Pasteur
Schiltigheim, 67303, France
Related Publications (1)
Sananes N, Roth GE, Aissi GA, Meyer N, Bigler A, Bouschbacher JM, Helmlinger C, Viville B, Guilpain M, Gaudineau A, Akladios CY, Nisand I, Langer B, Vayssiere C, Favre R. Acupuncture version of breech presentation: a randomized sham-controlled single-blinded trial. Eur J Obstet Gynecol Reprod Biol. 2016 Sep;204:24-30. doi: 10.1016/j.ejogrb.2016.07.492. Epub 2016 Aug 2.
PMID: 27521594RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Romain FAVRE, MD
Hôpitaux Universitaires de Strasbourg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2008
First Posted
December 23, 2008
Study Start
February 1, 2008
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
December 22, 2025
Record last verified: 2025-12