Acupuncture for Pain Relief During Induced Labour in Nulliparae

April 26, 2019 updated by: Ian Mackenzie, University of Oxford

Acupuncture for Pain Relief During Induced Labour in Nulliparae: a Randomised Controlled Study

The study was primarily designed to assess the role of acupuncture in reducing the need for epidural analgesia for pain relief during induced labour. The other outcomes of labour were to be observed in addition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was limited to women in their first pregnancy having labour induced for prolonged pregnancy or mild hypertension. The study involved randomised groups managed with manual acupuncture, electro acupuncture, sham acupuncture and a no-treatment control group.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • nulliparae
  • having labour induced for prolonged pregnancy or mild hypertension
  • no previous experience of acupuncture
  • give written informed consent

Exclusion Criteria:

  • all who do not meet the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: manual acupuncture
Sterile needles were inserted intramuscularly to a depth of 15-20mm until an unusual (De-Qi) sensation developed and remained inserted for 30-60 minutes and were manually manipulated during this time. The following bilateral acupoints on the hands and feet at Hegu (LI 4), Sanyinjiao (Sp 6) Kunlun (BL 60) and Zhiyin (BL 67)were used.
Procedure: acupuncture
The description of the acupuncture, whether manual, electro or sham, is as described for each of the individual groups.
Other Names:
  • Disposable needles Seirin DN04 0.20x30mm - 0.30x50mm.
  • Electronic Acupunctuscope AWQ-104L digital.
Experimental: electro acupuncture
Sterile needles were inserted intramuscularly to a depth of 15-20mm until an unusual (De-Qi) sensation developed and remained inserted for 30-60 minutes and were either electronically simulated withm2 Hz pulses of 0.5 msec duration for 30 minutes sufficient to cause non-painful muscle contractions. The following bilateral acupoints on the hands and feet at Hegu (LI 4), Sanyinjiao (Sp 6) Kunlun (BL 60) and Zhiyin (BL 67)were used.
Procedure: acupuncture
The description of the acupuncture, whether manual, electro or sham, is as described for each of the individual groups.
Other Names:
  • Disposable needles Seirin DN04 0.20x30mm - 0.30x50mm.
  • Electronic Acupunctuscope AWQ-104L digital.
Sham Comparator: Sham manual or electro acupuncture
Sterile needles were inserted adjacent to the specific acupuncture sites identified for the manual and electro groups to a depth of 1-1.5mm only and insufficient to provoke an unusual sensation and left in position for a 30-60 minutes. Those randomised to 'sham-manual' received no stimulation and those randomised to 'sham-electro' were connected to the electrical stimulator but the current not activated.
Procedure: acupuncture
The description of the acupuncture, whether manual, electro or sham, is as described for each of the individual groups.
Other Names:
  • Disposable needles Seirin DN04 0.20x30mm - 0.30x50mm.
  • Electronic Acupunctuscope AWQ-104L digital.
No Intervention: control group
Following randomisation to be control group, no specific treatment was organised at this time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of intrapartum epidural analgesia
Time Frame: within 72 hours of trial entry
epidural analgesia administered during labour
within 72 hours of trial entry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the outcome of labour
Time Frame: within 72 hours of trial entry
the outcomes of labour included: parenteral analgesia requirement, labour length, delivery mode, neonatal condition and postpartum haemorrhage
within 72 hours of trial entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Principal Investigator: I Z MacKenzie, FRCOG, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

July 15, 2010

First Submitted That Met QC Criteria

July 16, 2010

First Posted (Estimate)

July 19, 2010

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 26, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4874

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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