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

Tracking Information

First Received Date ^ICMJE

August 26, 2010

Last Updated Date

February 3, 2012

Start Date ^ICMJE

October 2008

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01197950 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Acupuncture to Reduce Labour Pain

Official Title ^ICMJE

A Randomized Controlled Trial of Acupuncture to Reduce Labour Pain

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Labour Pain

Intervention ^ICMJE

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
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

Study Arm (s)

Active Comparator: Manual Acupuncture
Intervention: Device: Manual Acupuncture
Experimental: Electro Acupuncture
Intervention: Device: Electro Acupuncture
No Intervention: Standard care

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

303

Completion Date

November 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT01197950

Other Study ID Numbers ^ICMJE

136-08

Has Data Monitoring Committee

Responsible Party

Lena Martensson, University of Skövde

Study Sponsor ^ICMJE

University of Skövde

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lena B Martensson, PhD

University of Skövde

Information Provided By

University of Skövde

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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