Cephalic Version by Acupuncture for Breech Presntation - Full Text View

Sponsored by:	University Hospital, Strasbourg, France
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00813683

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

MedlinePlus related topics: Acupuncture

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment
Official Title:	Study of Cephalic Version by Acupuncture for Breech Presntation.

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
1: Experimental Stimulation of "67 Bladder" point	Other: Acupuncture stimulation Acupuncture by stimulation of "67 Bladder" point
2: Placebo Comparator Stimulation of "45 Stomach" point (placebo)	Other: Acupuncture stimulation Acupuncture stimulation of "45 Stomach" point (placebo)

Eligibility

Criteria

Inclusion criteria:

Exclusion criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813683

Contacts

Contact: Romain FAVRE, MD

03.88.62.83.11

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
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

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

Keywords provided by University Hospital, Strasbourg, France:

Acupuncture, moxybustion,
Cephalic version,
Breech presentation

Study placed in the following topic categories:

Pregnancy Complications
Obstetric Labor Complications
Breech Presentation

ClinicalTrials.gov processed this record on January 13, 2009