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Use of Acupuncture for Stimulation of Labour

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ClinicalTrials.gov Identifier: NCT00279071
Recruitment Status : Terminated (exhausted personel after a long recruiting period)
First Posted : January 19, 2006
Last Update Posted : July 4, 2008
Sponsor:
Collaborators:
Information provided by:

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
Dystocia Device: Acupuncture og acupressure when diagnosed with dystocia Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
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 : October 2002
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Device: Acupuncture og acupressure when diagnosed with dystocia
    Acupuncture points: sp6 li4 ki3 ki6 bl60 Acupressure points: bl67

Outcome Measures

Secondary Outcome Measures :
  1. use of oxytocin [ Time Frame: additional need for oxytocin infusion in 1. stage and 2. stage ]
  2. number of contractions/30 minutes [ Time Frame: number og contractions in 1st. stage and 2nd. stage ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279071


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
More Information

ClinicalTrials.gov Identifier: NCT00279071     History of Changes
Other Study ID Numbers: 1-Modlock
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: July 4, 2008
Last Verified: July 2008

Keywords provided by Herning Hospital:
dystocia
stimulation
acupuncture
oxytocin

Additional relevant MeSH terms:
Dystocia
Obstetric Labor Complications
Pregnancy Complications