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Completed

NCT Number: NCT00890474

Moxibustion for Fetus in Breech Presentation

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.

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Key information

Conditions

Breech Presentation Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Uterine malformation
  • Placenta praevia
  • Transverse lie

Treatment and study plan

Moxibustion of the BL67 acupoint

Procedure

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.

Primary outcomes

  1. Cephalic presentation at delivery or before external cephalic version

    Time frame: end of pregnancy

Secondary outcomes

  1. Mode of delivery

    Time frame: end of pregnancy

  2. Women's views on the intervention

    Time frame: end of pregnancy

  3. External cephalic version

    Time frame: end of pregnancy

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • Loterie Romande
  • Swiss National Science Foundation

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
Apr 29, 2009
Registry last updated
Apr 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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