Use of Acupuncture for Stimulation of Labour

This study has been terminated.
(exhausted personel after a long recruiting period)
Sponsor:
Collaborators:
Ringkjøbing County Research Fond
Union of Midwives Research Fond
Information provided by:
Herning Hospital
ClinicalTrials.gov Identifier:
NCT00279071
First received: January 18, 2006
Last updated: July 1, 2008
Last verified: July 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Use of Acupuncture for Stimulation of Labour

Resource links provided by NLM:


Further study details as provided by Herning Hospital:

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

Enrollment: 100
Study Start Date: October 2002
Study Completion Date: March 2007
Intervention Details:
    Device: Acupuncture og acupressure when diagnosed with dystocia
    Acupuncture points: sp6 li4 ki3 ki6 bl60 Acupressure points: bl67
  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00279071     History of Changes
Other Study ID Numbers: 1-Modlock
Study First Received: January 18, 2006
Last Updated: July 1, 2008
Health Authority: Denmark: Ethics Committee

Keywords provided by Herning Hospital:
dystocia
stimulation
acupuncture
oxytocin

Additional relevant MeSH terms:
Dystocia
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on July 24, 2014