NCT01165099

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 15, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

3.9 years

First QC Date

July 15, 2010

Last Update Submit

April 26, 2019

Conditions

Pain

Keywords

acupunctureinduced labourlabour outcomenulliparaepain-reliefepidural during labour

Outcome Measures

Primary Outcomes (1)

  • the rate of intrapartum epidural analgesia

    epidural analgesia administered during labour

    within 72 hours of trial entry

Secondary Outcomes (1)

  • the outcome of labour

    within 72 hours of trial entry

Study Arms (4)

manual acupuncture

EXPERIMENTAL

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

electro acupuncture

EXPERIMENTAL

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

Sham manual or electro acupuncture

SHAM COMPARATOR

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

control group

NO INTERVENTION

Following randomisation to be control group, no specific treatment was organised at this time.

Interventions

acupuncturePROCEDURE

The description of the acupuncture, whether manual, electro or sham, is as described for each of the individual groups.

Also known as: Disposable needles Seirin DN04 0.20x30mm - 0.30x50mm., Electronic Acupunctuscope AWQ-104L digital.
Sham manual or electro acupunctureelectro acupuncturemanual acupuncture

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (2)

  • Lee H, Ernst E. Acupuncture for labor pain management: A systematic review. Am J Obstet Gynecol. 2004 Nov;191(5):1573-9. doi: 10.1016/j.ajog.2004.05.027.

    PMID: 15547526BACKGROUND

  • Mackenzie IZ, Xu J, Cusick C, Midwinter-Morten H, Meacher H, Mollison J, Brock M. Acupuncture for pain relief during induced labour in nulliparae: a randomised controlled study. BJOG. 2011 Mar;118(4):440-7. doi: 10.1111/j.1471-0528.2010.02825.x. Epub 2011 Jan 18.

    PMID: 21244615RESULT

MeSH Terms

Conditions

Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • I Z MacKenzie, FRCOG

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

July 15, 2010

First Posted

July 19, 2010

Study Start

August 1, 2005

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

April 30, 2019

Record last verified: 2019-04

Locations

GB(1)