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Complementary therapies for labour and birth study: a randomised controlled trial of antenatal integrative medicine for pain management in labour [with consumer summary]
Levett KM, Smith CA, Bensoussan A, Dahlen HG
BMJ Open 2016 Jul;6(7):e010691
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To evaluate the effect of an antenatal integrative medicine education programme in addition to usual care for nulliparous women on intrapartum epidural use. DESIGN: Open-label, assessor blind, randomised controlled trial. SETTING: 2 public hospitals in Sydney, Australia. POPULATION: 176 nulliparous women with low-risk pregnancies, attending hospital-based antenatal clinics. METHODS AND INTERVENTION: The Complementary Therapies for Labour and Birth protocol, based on the She Births and acupressure for labour and birth courses, incorporated 6 evidence-based complementary medicine techniques: acupressure, visualisation and relaxation, breathing, massage, yoga techniques, and facilitated partner support. Randomisation occurred at 24 to 36 weeks' gestation, and participants attended a 2-day antenatal education programme plus standard care, or standard care alone. MAIN OUTCOME MEASURES: Rate of analgesic epidural use. Secondary: onset of labour, augmentation, mode of birth, newborn outcomes. RESULTS: There was a significant difference in epidural use between the 2 groups: study group (23.9%) standard care (68.7%; risk ratio (RR) 0.37 (95% CI 0.25 to 0.55), p <= 0.001). The study group participants reported a reduced rate of augmentation (RR 0.54 (95% CI 0.38 to 0.77), p < 0.0001); caesarean section (RR 0.52 (95% CI 0.31 to 0.87), p = 0.017); length of second stage (mean difference -0.32 (95% CI -0.64 to 0.002), p = 0.05); any perineal trauma (0.88 (95% CI 0.78 to 0.98), p = 0.02) and resuscitation of the newborn (RR 0.47 (95% CI 0.25 to 0.87), p <= 0.015). There were no statistically significant differences found in spontaneous onset of labour, pethidine use, rate of postpartum haemorrhage, major perineal trauma (third and fourth degree tears/episiotomy), or admission to special care nursery/neonatal intensive care unit (p = 0.25). CONCLUSIONS: The Complementary Therapies for Labour and Birth study protocol significantly reduced epidural use and caesarean section. This study provides evidence for integrative medicine as an effective adjunct to antenatal education, and contributes to the body of best practice evidence. TRIAL REGISTRATION NUMBER: ACTRN12611001126909.
Reproduced with permission from the BMJ Publishing Group.

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