Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain

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

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of Acupuncture to Reduce Labour Pain

Conditions
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Labour Pain

Intervention / Treatment
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* Device: Manual Acupuncture
* Device: Electro Acupuncture


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual Acupuncture<br>Manual stimulation | Device: Manual Acupuncture<br>* 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.<br>* Other names: Acupuncture;|
| Experimental: Electro Acupuncture<br>Electrical and manual stimulation | Device: Electro Acupuncture<br>* 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.<br>* Other names: Acupuncture;|
| No Intervention: Standard care<br>No acupunture | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of Epidural Analgesia | Frequecy of epidural analgesia | From start of treatment until birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, labour, pain, pain relief, complementary