Clinical trial NCT01197950: Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain
Official title: A Randomized Controlled Trial of Acupuncture to Reduce Labour Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labour Pain
Keywords: acupuncture
labour
pain
pain relief
complementary
Lead sponsor: University of Skövde
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 303
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of manual acupuncture and electro-acupuncture on labour pain.

Detailed description: Acupuncture is used in obstetric care in spite of insufficient evidence of its potential to reduce labour pain. The findings so far are contradictory, which may reflect methodological limitations. The present study will take issues into account, such as sufficiently large sample to allow detection of possible differences between study groups; optimal timing of the intervention; controlling for intensity of the treatment; qualified training of persons giving the treatment; biological markers of pain and stress; possible effects on mother and infant; women's experiences such as overall birth experience and memory of pain.

Eligibility criteria: Inclusion Criteria:

* Admission to the labour ward in spontaneous onset of labour
* Latent or active phase of labour
* Nulliparity
* Singleton pregnancy, cephalic presentation
* Gestation: 37+0 to 41+6 (weeks + days)
* Expressed need for labour pain relief
* Swedish speaking (well enough to understand written and oral instructions)

Exclusion Criteria:

* No pharmacological pain relief within 24 hours prior to inclusion into the study
* Severe preeclampsia
* Treatment with oxytocin at the time point of allocation
* Treatment with anticoagulant
* Pacemaker

Primary outcomes:
measure: Use of Epidural Analgesia
timeFrame: From start of treatment until birth
Secondary outcomes:
Other outcomes:
Locations:
city: Skövde
country: Sweden
facility: School of Life Sciences, University of Skövde
Study officials:
affiliation: University of Skövde
name: Lena B Martensson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vixner L, Martensson LB, Schytt E. Acupuncture with manual and electrical stimulation for labour pain: a two month follow up of recollection of pain and birth experience. BMC Complement Altern Med. 2015 Jun 12;15:180. doi: 10.1186/s12906-015-0708-2.
citation: Vixner L, Martensson LB, Stener-Victorin E, Schytt E. Manual and electroacupuncture for labour pain: study design of a longitudinal randomized controlled trial. Evid Based Complement Alternat Med. 2012;2012:943198. doi: 10.1155/2012/943198. Epub 2012 Apr 17.
citation: Vixner L, Schytt E, Martensson LB. Associations between maternal characteristics and women's responses to acupuncture during labour: a secondary analysis from a randomised controlled trial. Acupunct Med. 2017 Jun;35(3):180-188. doi: 10.1136/acupmed-2016-011164. Epub 2016 Dec 16.
citation: Vixner L, Schytt E, Stener-Victorin E, Waldenstrom U, Pettersson H, Martensson LB. Acupuncture with manual and electrical stimulation for labour pain: a longitudinal randomised controlled trial. BMC Complement Altern Med. 2014 Jun 9;14:187. doi: 10.1186/1472-6882-14-187.