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Acupuncture to Reduce Labour Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lena Martensson, University of Skövde
ClinicalTrials.gov Identifier:
NCT01197950
First received: August 26, 2010
Last updated: February 3, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the effect of manual acupuncture and electro-acupuncture on labour pain.


Condition Intervention
Labour Pain
 Device: Manual Acupuncture
Device: Electro Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Acupuncture to Reduce Labour Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Skövde:

Primary Outcome Measures:
  • Experience of labour pain [ Time Frame: From start of treatment until birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of epidural analgesia [ Time Frame: From start of treatment until birth ] [ Designated as safety issue: No ]

Enrollment: 303
Study Start Date: October 2008
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Manual Acupuncture Device: Manual Acupuncture
The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.
Other Name: Acupuncture
Experimental: Electro Acupuncture Device: Electro Acupuncture
The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.
Other Name: Acupuncture
No Intervention: Standard care

Detailed Description:

Acupuncture is used in obstetric care in spite of insufficient evidence of its potential to reduce labour pain. The findings so far are contradictory, which may reflect methodological limitations. The present study will take issues into account, such as sufficiently large sample to allow detection of possible differences between study groups; optimal timing of the intervention; controlling for intensity of the treatment; qualified training of persons giving the treatment; biological markers of pain and stress; possible effects on mother and infant; women's experiences such as overall birth experience and memory of pain.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admission to the labour ward in spontaneous onset of labour
  • Latent or active phase of labour
  • Nulliparity
  • Singleton pregnancy, cephalic presentation
  • Gestation: 37+0 to 41+6 (weeks + days)
  • Expressed need for labour pain relief
  • Swedish speaking (well enough to understand written and oral instructions)

Exclusion Criteria:

  • No pharmacological pain relief within 24 hours prior to inclusion into the study
  • Severe preeclampsia
  • Treatment with oxytocin at the time point of allocation
  • Treatment with anticoagulant
  • Pacemaker
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197950

Locations
Sweden
School of Life Sciences, University of Skövde
Skövde, Sweden, SE-541 28
Sponsors and Collaborators
University of Skövde
Investigators
Principal Investigator: Lena B Martensson, PhD University of Skövde
  More Information

No publications provided

Responsible Party: Lena Martensson, PhD RNM Senior Lecturer, University of Skövde
ClinicalTrials.gov Identifier: NCT01197950     History of Changes
Other Study ID Numbers: 136-08
Study First Received: August 26, 2010
Last Updated: February 3, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University of Skövde:
acupuncture
labour
pain
pain relief
complementary

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013