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Acupuncture for Pain Relief During Induced Labour in Nulliparae

This study has been completed.
Sponsor:
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT01165099
First received: July 15, 2010
Last updated: July 16, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention
Pain
 Procedure: acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Pain Relief During Induced Labour in Nulliparae: a Randomised Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • the rate of intrapartum epidural analgesia [ Time Frame: within 72 hours of trial entry ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the outcome of labour [ Time Frame: within 72 hours of trial entry ] [ Designated as safety issue: Yes ]
    the outcomes of labour included: parenteral analgesia requirement, labour length, delivery mode, neonatal condition and postpartum haemorrhage


Enrollment: 105
Study Start Date: August 2005
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165099

Locations
United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: I Z MacKenzie, FRCOG University of Oxford
  More Information

Publications:

Responsible Party: Ian MacKenzie, University of Oxford
ClinicalTrials.gov Identifier: NCT01165099     History of Changes
Other Study ID Numbers: 4874
Study First Received: July 15, 2010
Last Updated: July 16, 2010
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Oxford:
acupuncture
induced labour
labour outcome
 nulliparae
pain-relief
epidural during labour

ClinicalTrials.gov processed this record on June 18, 2013