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Completed

NCT Number: NCT01487590

Cephalic Version by Acupuncture-Moxibustion for Breech Presentation

For breech presentation, the cesarean section rate is decreased by external cephalic version. This is a painful operation, with some rare but serious complications. The aim of this trial is to evaluate the effectiveness of acupuncture-moxibustion, a non-invasive technique, to correct breech presentation before 37 weeks of gestation.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Jeanne de Flandre, CHRU de Lille

Lille, France

About this study

Monocentric controlled randomized trial in a simple blind fashion, comparing acupuncture-moxibustion versus a placebo in singleton pregnancies with breech presentation between 33+5 to 35+5 weeks of gestation. The intervention arm consists of acupuncture-moxibustion at the BL67 acupuncture point, for six seances of twenty minutes two days apart. In the placebo group, the cold light of an inactivated laser is to be applied in the same point during the same time. When cephalic version fail, a manual external cephalic version is to be proposed. The main outcome measure is cephalic presentation at 37+2 weeks of gestation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • breech presentation,
  • SINGLETON

Exclusion criteria

  • maternal age between 18 ans 45,
  • multiple gestation,
  • fetal or uterine malformation,
  • premature rupture of membranes

Treatment and study plan

Acupuncture moxibustion

Other

Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.

Other names: no applicable

Placebo

Other

Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart

Other names: no applicable

Primary outcomes

  1. Cephalic presentation

    Time frame: at 37+2 weeks of gestation

    Each participant women will be examined at 37+2 weeks to determine the fetal presentation. Ultrasonography will be performed in case of doubt.

Secondary outcomes

  1. Successful manual external cephalic version after intervention

    Time frame: Before 41 weeks of gestation

    In case of failure of acupuncture/moxibustion or placebo, the success of manual external cephalic version will be studied.

  2. Cephalic presentation at delivery

    Time frame: Date of delivery

    The rate of cephalic presentation at delivery will be described

  3. Cesarean section rate

    Time frame: Date of delivery

    The cesarean section rate will be described

  4. Premature rupture of membranes

    Time frame: Before delivery

    The rate of premature rupture of membranes will be described

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

A Simple Blind Controlled Randomized Trial: Cephalic Version by Acupuncture-moxibustion vs Placebo for Breech Presentation

Acronym: ACUVERSE

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Dec 7, 2011
Registry last updated
Dec 2, 2025

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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