Evaluation of the synthetic osmotic dilator (Dilapan-S®) for induction of labour through a multicentre retrospective registry of real-world data in the United Kingdom.

Introduction : In 2015, Dilapan-S was approved by the FDA for cervical ripening in pregnancy. This synthetic hygroscopic agent for labour induction has increased the options for initiating labour. This real-world evaluation aims to determine if Dilapan-S use in routine practice within UK demonstrates outcomes achieved by studies in other health systems. Materials and methods : Five large maternity units were recruited to the study due to their routine use of Dilapan-S. Primary outcomes were duration in situ and insertion-delivery interval. Secondary outcomes were the number of dilators used, and Bishop score change. Analgesia use during and after insertion and post-induction complications were also recorded, as was mode of delivery. Results: 1,509 women were observed retrospectively. During insertion, 94.2% did not experience any complications. 55% women were suitable for ARM after one round of Dilapan-S. Mean insertion-delivery interval was 50.4hrs. Mean Bishop score increase was +2.1. The mean dilators used was five. Oxytocin was required in 59% of women; vaginal delivery rate was 59.5%. 83% of the women had no complications. 3.5% of babies were admitted to the neonatal unit; 90.2% and 97% had Apgars of 8-10 at 1 and 5 minutes, respectively. Conclusion: Dilapan-S is an effective method for induction of labour in routine clinical practice. As with other observational and randomised studies, its use is associated with low complication rates. This Real-World Evidence project assessing retrospective cohorts showed that time from insertion- delivery is more than that observed previously, largely due to delay in waiting for artificial rupture of membranes.