Acupuncture for Pain Relief During Induced Labour in Nulliparae

NCT ID: NCT01165099

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

acupuncture

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

acupuncture

Intervention Type PROCEDURE

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

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.

Group Type SHAM_COMPARATOR

acupuncture

Intervention Type PROCEDURE

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

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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acupuncture

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

Intervention Type PROCEDURE

Other Intervention Names

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Disposable needles Seirin DN04 0.20x30mm - 0.30x50mm. Electronic Acupunctuscope AWQ-104L digital.

Eligibility Criteria

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Inclusion Criteria

* nulliparae
* having labour induced for prolonged pregnancy or mild hypertension
* no previous experience of acupuncture
* give written informed consent
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Ian Mackenzie

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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I Z MacKenzie, FRCOG

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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John Radcliffe Hospital

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 15547526 (View on PubMed)

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.

Reference Type RESULT
PMID: 21244615 (View on PubMed)

Other Identifiers

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4874

Identifier Type: -

Identifier Source: org_study_id

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