Measuring the clinical effectiveness and healthcare experiences for women undergoing a balloon induction of labour, where the balloon is used for 6 hours compared to 12 hours.

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Induction of labour (IOL) is one of the most frequently performed obstetric interventions. In high-income countries nearly one-third of all pregnant women undergo IOL. The process of IOL commonly involves cervical ripening, using mechanical or pharmacological methods; however, the optimum protocol of IOL remains undetermined. For almost 50 years, balloon catheters have been used to mechanically ripen the cervix. Balloon catheters apply direct pressure on the internal os of the cervix, stretching the lower uterine segment and indirectly increasing release of endogenous prostaglandins. In recent years, there has been a shift in clinical practice favouring mechanical methods in response to growing evidence of both efficacy and safety. In randomised controlled trials and meta-analyses mechanical methods appear comparable to pharmacological methods for successful IOL without the complication of uterine hyper-stimulation. Trends toward a reduction in instrumental births, fetal acidaemia and post-partum haemorrhage have also been observed with balloon IOL. IOL using a single or double balloon catheter typically involves removal of the catheter approximately 12 hours after insertion, followed by an artificial rupture of membranes (ARM) and commencement of an oxytocin infusion. Whilst there is good data supporting its efficacy in ripening the cervix, there is limited information to guide exactly how long a balloon catheter should remain in situ. The product recommendation states “up to 12 hours”. There are just two abstracts reporting on small clinical trials comparing a 6-hour versus 12-hour insertion. The methods do not describe how the IOL was managed following removal of the balloon. These data are under-powered but nevertheless reassuring that an earlier removal of the balloon catheter is likely associated with a shorter duration of labour and is unlikely to be associated with a difference in mode of birth. There is evidence to support that a longer duration of induced labour is associated with both a poorer healthcare experience and increased costs. Hence earlier removal of the balloon catheter shows promise as a method to reduce cost, and improve the healthcare experience for women without altering clinical outcomes. This study therefore aims to explore the clinical effectiveness and healthcare experience of women undergoing an IOL using a balloon catheter where the balloon is left in-situ for a shorter versus longer duration of time.

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