NCT00890474

Brief Summary

Objective: To evaluate moxibustion of the BL67 acupoint between 34 and 38 weeks of gestation to facilitate cephalic version of breech presentation in a Western setting. The hypothesis is that moxibustion increase the likelihood of cephalic version. Design: Randomised controlled trial Setting: University hospital. Population: A total of 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation will be randomised to moxibustion (n=106) or expectant management (n=106). Main Outcome Measure: Cephalic presentation at delivery or before external cephalic version.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
Last Updated

April 29, 2009

Status Verified

April 1, 2009

Enrollment Period

4.2 years

First QC Date

April 28, 2009

Last Update Submit

April 28, 2009

Conditions

Breech Presentation

Keywords

Breech presentation at 34 to 36 weeks of gestation

Outcome Measures

Primary Outcomes (1)

  • Cephalic presentation at delivery or before external cephalic version

    end of pregnancy

Secondary Outcomes (3)

  • Mode of delivery

    end of pregnancy

  • Women's views on the intervention

    end of pregnancy

  • External cephalic version

    end of pregnancy

Study Arms (2)

Moxibustion

EXPERIMENTAL
Procedure: Moxibustion of the BL67 acupoint

Control

NO INTERVENTION

Interventions

Moxibustion of the BL67 acupointPROCEDURE

Moxibustion sessions every day (every other day in hospital, self-administration at home the other day) during a maximum of 14 days. Stopped if cephalic version.

Moxibustion

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Breech presentation
  • to 36 weeks of gestation
  • Single fetus

You may not qualify if:

  • Uterine malformation
  • Placenta praevia
  • Transverse lie

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

Related Publications (1)

  • Guittier MJ, Pichon M, Dong H, Irion O, Boulvain M. Moxibustion for breech version: a randomized controlled trial. Obstet Gynecol. 2009 Nov;114(5):1034-1040. doi: 10.1097/AOG.0b013e3181bc707a.

    PMID: 20168104DERIVED

MeSH Terms

Conditions

Breech Presentation

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 28, 2009

First Posted

April 29, 2009

Study Start

October 1, 2004

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

April 29, 2009

Record last verified: 2009-04

Locations

CH(1)