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Completed

NCT Number: NCT01197950

Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain

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

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

School of Life Sciences, University of Skövde

Skövde, SE-541 28, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual acupuncture

Device

The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.

Other names: Acupuncture

electro acupuncture

Device

The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.

Other names: Acupuncture

Primary outcomes

  1. Use of Epidural Analgesia

    Time frame: From start of treatment until birth

    Frequecy of epidural analgesia

Sponsors and collaborators

Lead sponsor

University of Skövde

Other

Registry information

Official study title

A Randomized Controlled Trial of Acupuncture to Reduce Labour Pain

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 9, 2010
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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