RESUMO
OBJECTIVES: We aimed to determine the feasibility of conducting a randomised controlled trial (RCT) on the use of aromatherapy during labour as a care option that could improve maternal and neonatal outcomes. DESIGN: RCT comparing aromatherapy with standard care during labour. SETTING: District general maternity unit in Italy. SAMPLE: Two hundred and fifty-one women randomised to aromatherapy and 262 controls. METHODS: Participants randomly assigned to administration of selected essential oils during labour by midwives specifically trained in their use and modes of application. MAIN OUTCOME MEASURES: Intrapartum outcomes were the following: operative delivery, spontaneous delivery, first- and second-stage augmentation, pharmacological pain relief, artificial rupture of membranes, vaginal examinations, episiotomy, labour length, neonatal wellbeing (Apgar scores) and transfer to neonatal intensive care unit (NICU). RESULTS: There were no significant differences for the following outcomes: caesarean section (relative risk [RR] 0.99, 95% CI: 0.70-1.41), ventouse (RR 1.5, 95% CI: 0.31-7.62), Kristeller manoeuvre (RR 0.97, 95% CI: 0.64-1.48), spontaneous vaginal delivery (RR 0.99, 95% CI: 0.75-1.3), first-stage augmentation (RR 1.01, 95% CI: 0.83-1.4) and second-stage augmentation (RR 1.18, 95% CI: 0.82-1.7). Significantly more babies born to control participants were transferred to NICU, 0 versus 6 (2%), P = 0.017. Pain perception was reduced in aromatherapy group for nulliparae. The study, however, was underpowered. CONCLUSION: This study demonstrated that it is possible to undertake an RCT using aromatherapy as an intervention to examine a range of intrapartum outcomes, and it provides useful information for future sample size calculations.