Fetomaternal Outcomes in Induction of Labour with Intracervical Foley's Catheter Alone Versus Induction with Foley's Catheter Plus Single Dose Dinoprostone

Background: Combining a transcervical Foley catheter with dinoprostone may accelerate cervical ripening, but the added pharmacological stimulus could alter maternal and neonatal safety. This study compared prespecified fetomaternal outcomes after induction with a Foley catheter alone and after induction with a Foley catheter plus a single dose of dinoprostone. Material and Methods: This prospective observational comparison included 100 primigravid women at 37 weeks of gestation or later with singleton, cephalic pregnancies, intact membranes, a reactive fetal heart-rate trace, and an unfavourable cervix. Fifty women received an intracervical Foley catheter and 50 received the catheter with 0.5 mg intracervical dinoprostone gel. Maternal outcomes were postpartum haemorrhage, puerperal sepsis, intrapartum pyrexia, and uterine tachysystole. Fetal distress, 5-minute Apgar score, and neonatal intensive care unit admission were assessed. Binary outcomes were reanalysed with Fisher's exact test, risk ratios, risk differences, and 95% confidence intervals. Results: Postpartum haemorrhage occurred in 2 of 50 women after Foley catheter alone and 3 of 50 after the combined method (risk ratio 1.50, 95% confidence interval 0.26 to 8.60). Puerperal sepsis, intrapartum pyrexia, and tachysystole each occurred in 1 of 50 versus 2 of 50 women. Fetal distress occurred in 3 of 50 versus 5 of 50 pregnancies (risk ratio 1.67, 95% confidence interval 0.42 to 6.60), and neonatal intensive care admission occurred in 4 of 50 versus 5 of 50 newborns (risk ratio 1.25, 95% confidence interval 0.36 to 4.38). Mean 5-minute Apgar scores were 8.94 (standard deviation 1.08) and 9.28 (standard deviation 0.97), respectively; the mean difference was 0.34 (95% confidence interval -0.07 to 0.75). No comparison reached statistical significance. Conclusion: A Foley catheter combined with one dose of dinoprostone did not produce a statistically demonstrable increase in the recorded maternal or neonatal adverse outcomes. The low event counts and wide confidence intervals do not establish equivalence or exclude clinically important differences. Larger, adequately powered studies with standardised safety definitions are required.

Keywords: Labour induction, cervical ripening, Foley catheter, dinoprostone, maternal safety, neonatal outcome.