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NCT01165099 Clinical Trial

Acupuncture for Pain Relief During Induced Labour in Nulliparae

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01165099
Other study ID # 4874
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2005
Est. completion date July 2009

Study information
Verified date April 2019
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United Kingdom John Radcliffe Hospital Oxford

Sponsors (1)
Lead Sponsor Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Lee H, Ernst E. Acupuncture for labor pain management: A systematic review. Am J Obstet Gynecol. 2004 Nov;191(5):1573-9. Review. — View Citation

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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary the rate of intrapartum epidural analgesia epidural analgesia administered during labour within 72 hours of trial entry
Secondary the outcome of labour the outcomes of labour included: parenteral analgesia requirement, labour length, delivery mode, neonatal condition and postpartum haemorrhage within 72 hours of trial entry
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