Dilapan-S osmotic dilator compared to Dinoprostone for labour induction in 860 pregnant women

Induction of labour is a common obstetrical procedure, required in 25-30% of pregnancies in high-resource countries. Traditional methods involve pharmacological agents like prostaglandins (e.g., Dinoprostone) or surgical membrane rupture, which can sometimes lead to premature or hypertonic contractions, potentially causing fetal distress. Dilapan-S, an osmotic cervical dilator, offers a non-pharmacological alternative by mimicking natural cervical ripening without inducing contractions, addressing a critical gap in current induction strategies.

This randomized controlled trial (RCT) recruited 860 women with a single, full-term pregnancy requiring labour induction and not considered high-risk. Participants were equally randomized to receive either Dilapan-S osmotic cervical dilators or the standard prostaglandin drug, Dinoprostone vaginal insert. The study compared the speed at which labour commenced, the mode of delivery (vaginal vs. C-section), and any associated side effects. Additionally, patient satisfaction and anxiety levels during the induction process were assessed via a short questionnaire completed post-delivery.

This completed randomized controlled trial aimed to evaluate the efficacy and safety of Dilapan-S compared to Dinoprostone for cervical ripening and labour induction. The primary outcomes for comparison included the time from induction to active labour and the mode of delivery. Secondary outcomes focused on the incidence of adverse events for both mother and baby, as well as maternal satisfaction and anxiety scores related to the induction experience. Specific quantitative results, including p-values, percentages, and confidence intervals for these comparisons, are pending publication. However, the study design was robust, with a target enrollment of 860 participants to provide sufficient statistical power for detecting clinically meaningful differences. The core hypothesis is that Dilapan-S could offer a safer, non-pharmacological alternative.

The investigators will specifically compare the speed of labour commencement, the mode of delivery, and the occurrence of any side effects between the Dilapan-S and Dinoprostone groups.