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Cephalic Version by Acupuncture for Breech Presntation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00813683
First received: December 22, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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 placebo.

Protocol :

  • Inclusion of patients with fetus in breech presentation at 32-33 weeks of pregnancy.
  • Randomization. First group : acupuncture by stimulation of "67 Bladder" point.Second group : stimulation of "45 Stomach" point (placebo).
  • Ultrasonographic control of presentation at 35 weeks.

Condition Intervention
Breech Presentation
 Other: Acupuncture stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Study of Cephalic Version by Acupuncture for Breech Presntation.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Cephalic or breech presentation (ultrasonographic control at 35 weeks of pregnancy) [ Time Frame: 35 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increase of fetal movements [ Time Frame: 35 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: February 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Stimulation of "67 Bladder" point
 Other: Acupuncture stimulation
Acupuncture by stimulation of "67 Bladder" point
Placebo Comparator: 2
Stimulation of "45 Stomach" point (placebo)
 Other: Acupuncture stimulation
Acupuncture stimulation of "45 Stomach" point (placebo)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Single pregnancy at 32-34 weeks of pregnancy.
  • Fetus in breech presentation.

Exclusion criteria:

  • Twins.
  • Story of preterm birth or any preterm birth risk
  • Fetal malformations, abnormal karyotype
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813683

Contacts
Contact: Romain FAVRE, MD 03.88.62.83.11 romain.favre@wanadoo.fr

Locations
France
Service de Gynécologie-Obstétrique, Hôpital SIHCUS - CMCO, 19 rue Louis Pasteur Recruiting
Schiltigheim, France, 67303
Contact: Romain FAVRE, MD     03.88.62.83.11     romain.favre@wanadoo.fr    
Sub-Investigator: Bruno LANGER, MD            
Sub-Investigator: Brigitte VIVILLE, MD            
Sub-Investigator: Christine HELMLINGER, MD            
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Romain FAVRE, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: Emmanuel LAVOUE, Directeur Adjoint, University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00813683     History of Changes
Other Study ID Numbers: 3993
Study First Received: December 22, 2008
Last Updated: December 22, 2008
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Acupuncture, moxybustion,
Cephalic version,
Breech presentation

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

ClinicalTrials.gov processed this record on May 23, 2013