Manual and electroacupuncture for labour pain. Study design of a longitudinal randomized controlled trial

Introduction: Results from previous acupuncture studies for labour pain are contradictory and lack important information on methodology. The sample sizes are in general small, information about the intervention such as needle placement, number of acupuncture points, type of stimulation, and duration of treatment, is often sparse or lacking However, studies indicate that acupuncture has a positive effect on women’s experiences of labour pain. Aim: The aim of the present study was to evaluate the efficacy of two different acupuncture stimulations, manual or electrical stimulation, compared with standard care in the relief of labour pain. Our hypothesis is that acupuncture with manual or electrical stimulation is more effective than standard care in the relief of labor pain, and that acupuncture with electrical stimulation is the most effective.Outcome measures: Primary outcome: Labour pain measured with visual analogue scale (VAS). Secondary outcomes are use of epidural analgesia, experience of relaxation, labour outcomes and infant outcomes. Biochemical markers of proinflammatory cytokines, memory of labour pain and overall childbirth experience.Methods: The study was designed as a randomized controlled trial based on Western medical theories. Nulliparous women with normal pregnancies admitted to the delivery ward after a spontaneous onset of labour were randomly allocated into one of three groups: manual acupuncture, electroacupuncture or standard care. Sample size calculation gave 101 women in each group, including a total of 303 women. VAS was used for assessing pain every 30 minutes for five hours and thereafter every hour until birth. Questionnaires were distributed before treatment, directly after the birth, and at one day and two months postpartum. Blood samples were collected before and after the first treatment.At the conference, information on the design of the study will be presented and the considerations of whether to use placebo controls or not will be discussed.ClinicalTrials.gov: NCT01197950