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Cephalic Version by Acupuncture for Breech Presentation

Primary Purpose

Breech Presentation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Acupuncture stimulation
Acupuncture stimulation
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breech Presentation focused on measuring Acupuncture, moxybustion,, Cephalic version,, Breech presentation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

Stimulation of "67 Bladder" point

Stimulation of "45 Stomach" point (sham)

Outcomes

Primary Outcome Measures

Cephalic or breech presentation (ultrasonographic control at 35 weeks of pregnancy)

Secondary Outcome Measures

general outcomes about external cephalic version, delivery and neonates

Full Information

First Posted
December 22, 2008
Last Updated
October 19, 2015
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT00813683
Brief Title
Cephalic Version by Acupuncture for Breech Presentation
Official Title
Study of Cephalic Version by Acupuncture for Breech Presentation.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Presentation
Keywords
Acupuncture, moxybustion,, Cephalic version,, Breech presentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
259 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Stimulation of "67 Bladder" point
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Stimulation of "45 Stomach" point (sham)
Intervention Type
Other
Intervention Name(s)
Acupuncture stimulation
Intervention Description
Acupuncture by stimulation of "67 Bladder" point
Intervention Type
Other
Intervention Name(s)
Acupuncture stimulation
Intervention Description
Acupuncture stimulation of "45 Stomach" point (sham)
Primary Outcome Measure Information:
Title
Cephalic or breech presentation (ultrasonographic control at 35 weeks of pregnancy)
Time Frame
35 weeks
Secondary Outcome Measure Information:
Title
general outcomes about external cephalic version, delivery and neonates
Time Frame
35 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain FAVRE, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Gynécologie-Obstétrique, Hôpital SIHCUS - CMCO, 19 rue Louis Pasteur
City
Schiltigheim
ZIP/Postal Code
67303
Country
France

12. IPD Sharing Statement

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Cephalic Version by Acupuncture for Breech Presentation

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