Cephalic Version by Acupuncture for Breech Presentation

Breech Presentation Clinical Trial

Official title:

Study of Cephalic Version by Acupuncture for Breech Presentation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813683
• Other study ID #: 3993
• Status: Completed
• Phase: N/A
• First received: December 22, 2008
• Last updated: October 19, 2015
• Start date: February 2008
• Est. completion date: May 2014

Study information

• Verified date: December 2008
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breech Presentation

Intervention

Other:
• Acupuncture stimulation
Acupuncture by stimulation of "67 Bladder" point
• Acupuncture stimulation
Acupuncture stimulation of "45 Stomach" point (sham)

Locations

Country	Name	City	State
France	Service de Gynécologie-Obstétrique, Hôpital SIHCUS - CMCO, 19 rue Louis Pasteur	Schiltigheim

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cephalic or breech presentation (ultrasonographic control at 35 weeks of pregnancy)		35 weeks	No
Secondary	general outcomes about external cephalic version, delivery and neonates		35 weeks	No