Cephalic Version by Acupuncture for Breech Presentation

October 19, 2015 updated by: University Hospital, Strasbourg, France

Study of Cephalic Version by Acupuncture for Breech Presentation.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

259

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Schiltigheim, France, 67303
        • Service de Gynécologie-Obstétrique, Hôpital SIHCUS - CMCO, 19 rue Louis Pasteur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Stimulation of "67 Bladder" point
Other: Acupuncture stimulation
Acupuncture by stimulation of "67 Bladder" point
Other: Acupuncture stimulation
Acupuncture stimulation of "45 Stomach" point (sham)
SHAM_COMPARATOR: 2
Stimulation of "45 Stomach" point (sham)
Other: Acupuncture stimulation
Acupuncture by stimulation of "67 Bladder" point
Other: Acupuncture stimulation
Acupuncture stimulation of "45 Stomach" point (sham)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cephalic or breech presentation (ultrasonographic control at 35 weeks of pregnancy)
Time Frame: 35 weeks
35 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
general outcomes about external cephalic version, delivery and neonates
Time Frame: 35 weeks
35 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Romain FAVRE, MD, Hopitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

December 22, 2008

First Submitted That Met QC Criteria

December 22, 2008

First Posted (ESTIMATE)

December 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3993

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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