Cephalic Version by Acupuncture for Breech Presentation

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. Identifier: NCT00813683
Recruitment Status : Completed
First Posted : December 23, 2008
Last Update Posted : October 20, 2015
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.

Condition or disease Intervention/treatment Phase
Breech Presentation Other: Acupuncture stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study of Cephalic Version by Acupuncture for Breech Presentation.
Study Start Date : February 2008
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Stimulation of "67 Bladder" point
Other: Acupuncture stimulation
Acupuncture by stimulation of "67 Bladder" point
Sham Comparator: 2
Stimulation of "45 Stomach" point (sham)
Other: Acupuncture stimulation
Acupuncture stimulation of "45 Stomach" point (sham)

Primary Outcome Measures :
  1. Cephalic or breech presentation (ultrasonographic control at 35 weeks of pregnancy) [ Time Frame: 35 weeks ]

Secondary Outcome Measures :
  1. general outcomes about external cephalic version, delivery and neonates [ Time Frame: 35 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00813683

Service de Gynécologie-Obstétrique, Hôpital SIHCUS - CMCO, 19 rue Louis Pasteur
Schiltigheim, France, 67303
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Romain FAVRE, MD Hôpitaux Universitaires de Strasbourg

Responsible Party: University Hospital, Strasbourg, France Identifier: NCT00813683     History of Changes
Other Study ID Numbers: 3993
First Posted: December 23, 2008    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: December 2008

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

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