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Use of Acupuncture for Stimulation of Labour

Sponsor
Herning Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT00279071
Collaborator
Ringkjøbing County Research Fond (Other), Union of Midwives Research Fond (Other)
100
Enrollment
53
Duration (Months)

Study Details

Study Description

Brief Summary

Hypothesis:Acupuncture can be used as stimulation of labour in case of primary og secondary inertia.

A randomized controlled trial including 150 pregnant women Acupuncture has become a natural part of the range of obstetric treatments offered in danish delivery wards, but there is only little evidence to the effect of the acupuncture.

The women are randomized into to groups.

  1. Acupuncture, Acu.points: KI3, Ki6, SP6, BL60, LI4, BL67(acupressure)

  2. No treatment

The women will be asked in case beginning signs of inertia, if they want to parcipitate in the trial.

Inclusion criteria:

  1. Normal pregnancy

  2. In labour (orificium < 8 cm), 37th week or thereafter

  3. Ruptured membranes

  4. Primary or secondary inertia

The women will just before randomization be vaginally explored and fetal heart monitored. The meassure of effect happens two hours after randomization.

The midwife who measures the effect, is blinded to the treatment or lack of, and also on the including exploration.

Secondary effect meassures: length of labour, use of oxytocin and number of contracions pr/min meassured twice:

  1. before the randomization and again 1 hour after randomization.
Condition or Disease Intervention/Treatment Phase
  • Device: Acupuncture og acupressure when diagnosed with dystocia
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Use of Acupuncture for Stimulation of Labour
Study Start Date :
Oct 1, 2002
Actual Study Completion Date :
Mar 1, 2007

Outcome Measures

Primary Outcome Measures

    Secondary Outcome Measures

    1. use of oxytocin [additional need for oxytocin infusion in 1. stage and 2. stage]

    2. number of contractions/30 minutes [number og contractions in 1st. stage and 2nd. stage]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Normal pregnancy

    2. In labour (orificium < 8 cm), 37th week or thereafter

    3. Ruptured membranes

    4. Primary or secondary inertia -

    Exclusion Criteria:

    1. Pathological pregnancy

    2. Pathological labour

    3. Medical diseases

    4. Women who do not speak and undrestand danish

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Herning Hospital
    • Ringkjøbing County Research Fond
    • Union of Midwives Research Fond

    Investigators

    • Study Chair: Kjeld Rasmussen, obst. dr.med, Obstetric ward Herning and Holstebro hospitals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00279071
    Other Study ID Numbers:
    • 1-Modlock
    First Posted:
    Jan 19, 2006
    Last Update Posted:
    Jul 4, 2008
    Last Verified:
    Jul 1, 2008
    Keywords provided by , ,
    dystocia
    stimulation
    acupuncture
    oxytocin
    Additional relevant MeSH terms:
    Dystocia

    Study Results

    No Results Posted as of Jul 4, 2008