Cephalic Version by Acupuncture for Breech Presentation

NCT ID: NCT00813683

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breech Presentation

Keywords

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Acupuncture, moxybustion, Cephalic version, Breech presentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Stimulation of "67 Bladder" point

Group Type EXPERIMENTAL

Acupuncture stimulation

Intervention Type OTHER

Acupuncture by stimulation of "67 Bladder" point

2

Stimulation of "45 Stomach" point (sham)

Group Type SHAM_COMPARATOR

Acupuncture stimulation

Intervention Type OTHER

Acupuncture stimulation of "45 Stomach" point (sham)

Interventions

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Acupuncture stimulation

Acupuncture by stimulation of "67 Bladder" point

Intervention Type OTHER

Acupuncture stimulation

Acupuncture stimulation of "45 Stomach" point (sham)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Romain FAVRE, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

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Service de Gynécologie-Obstétrique, Hôpital SIHCUS - CMCO, 19 rue Louis Pasteur

Schiltigheim, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 27521594 (View on PubMed)

Other Identifiers

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3993

Identifier Type: -

Identifier Source: org_study_id