A Randomized Controlled Trial Comparing Transcervical Foley Catheter With and Without Extra Amniotic Saline Infusion for Induction of Labour

Objective: To compare the efficacy and safety of transcervical foley catheter alone to transcervical foley catheter with extra-amniotic saline infusion for labour induction and cervical ripening in women with an unfavourable cervix. Method: 100 pregnant women (study population) were allocated randomly into two groups. First 50 patients were assigned to treatment with transcervical foley catheter with extra-amniotic saline infusion (study group), and next 50 were assigned to transcervical foley catheter alone (control group). All patients were receiving intravenous oxytocin. All women were kept under antibiotic coverage during the whole procedure. Primary study outcome(induction to delivery time) and secondary outcome (mode of delivery, endometritis, chorioamnionitis, apgar scoring etc.) were recorded. Results: 100 women were included in this study, 50 in each group. Baseline demographic characteristics including age, parity, pre-induction bishop’s score, indication for induction were comparable between both groups. The mean induction delivery interval in study and control group were 10.57 hrs ±3.24 and 12.43 hrs. ± 3.24 respectively. P value was 0.011 which was statistically significant. Post induction bishop’s score was 9.82 ± 1.521 in study group and 9.24 ± 1.271 in controlled group, (P = 0.04) which was statistically significant. Maternal complications were very few and similar in both groups. Apgar score in 5 mins was 9.06 ± 0.998 in study group and 8.84 ± 1.167 in control group. 18% of newborn in study group and 26% of newborn in control group admitted in SNCU. Conclusion: Foley catheter with extra-amniotic saline infusion is more efficacious method for induction of labour when compared to induction of labour with foley alone. Both methods are safe as they cause less neonatal and maternal complications and few admission of early neonates in SNCU.