A feasibility randomised controlled trial of acupressure to assist spontaneous labour for primigravid women experiencing a post-date pregnancy

Abstract

OBJECTIVE: this Australian feasibility study aimed to determine; the willingness of women experiencing a post-date pregnancy to participate in a randomised controlled trial (RCT) of acupressure and compliance with the study protocol. The study also aimed to determine the effect size of the primary outcome in order to calculate a sample size for a future appropriately powered RCT. DESIGN: a two-arm randomised controlled trial. Staff providing clinical care were blinded to group allocation unless the participant disclosed study participation. SETTING: maternity services at two outer metropolitan public hospitals in New South Wales, Australia PARTICIPANTS: sixty seven healthy primigravid women experiencing a singleton cephalic pregnancy at 40 weeks+/-2 days gestation were assessed as eligible to participate and were provided with study information. INTERVENTION: both groups received standard clinical care, with the intervention group also receiving verbal and written instructions on the self-administration of three acupoints (Spleen 6, Large Intestine 4, and Gall Bladder 21) to be used until spontaneous or induced labour began. MEASUREMENTS: assessment of feasibility included determining recruitment rate and acceptability of an RCT for a CAM modality, and acupressure treatment compliance, via participant surveys. The primary clinical outcome was spontaneous onset of labour. FINDINGS: from the 67 women eligible during the timeframe for the study, 44 women (65.6%) agreed to participate and were randomised. There was no statistically significant difference in rate of spontaneous onset of labour (50% acupressure vs 41% control). Twenty nine participant surveys were returned (65.9%). In the intervention group there was a high compliance with the acupressure protocol (83%) and the use of the three acupoints (94%). CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: this feasibility study revealed that pregnant women are interested in the use of CAM, and acupressure in particular, for the initiation of labour. Most women found it acceptable to be randomised to receive the intervention. While the 9% difference in the primary outcome was not statistically significant it is the best estimate of the treatment effect for calculating a sample size of 994 for a future RCT with 80% power, alpha 0.05. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ANZCTR:12613000145707.