BackgroundFoley catheter insertion is frequently utilized for cervical ripening during the induction of labour. However, the insertion failure, safety, maternal side effects, complications and satisfaction of digital compared to speculum-guided Foley catheter placement have not been evaluated in a large trial involving primigravida. ObjectivesThe study aimed to compare the insertion failure rate of digital and speculum-based transcervical Foley catheter placement in primigravida. The co-primary outcome was insertion-associated pain. The secondary outcomes were time required for successful insertion, maternal satisfaction, and maternal complications within 24 hours of Foley insertion. MethodsThis randomized, open-label, parallel-arm, non-inferiority clinical trial was performed in a large tertiary care university hospital. Primigravida >18 years of age with term gestation (≥37 weeks) were included in this study. Additional inclusion criteria for enrolment in this study were singleton pregnancy with a cephalic presentation, intact membrane, Bishop score ≤5 and reassuring pre-induction foetal heart rate tracing. All women planned for cervical ripening were assessed for eligibility and were randomized into digital or speculum arms. Foley catheter insertion was performed in a supine lithotomy position. Vaginal and cervical cleaning were performed before insertion. A 22-French Foley balloon catheter was guided digitally or via speculum to position the bulb at the level of the internal os using water-soluble lubricant. Insertion-associated pain was measured using visual numeric rating scale (VNRS) and maternal satisfaction was assessed using a set of questions. Results469 pregnant women were assessed for eligibility, and 446 patients were enrolled and randomized. The median age of the parturients was 24 (19-40) and 24 (18-38) years, respectively. The body mass index, gestational age at randomization, incidence of post-dated pregnancy and pre-randomization Bishop scores were comparable. Insertion failure was observed in 24 (10.8%) and 17 (7.6%) of women in digital and speculum arm, respectively (RR= 1.41; 95% CI, 0.78-2.55; P=0.25). Requirements of more than one attempt (5.4% vs 3.6%) followed by change in hands (3.6% vs 2.7%) were the most common reasons for insertion failure. The median (interquartile range) VNRS was comparable (6.00 (2-9) vs 5.00 (2-10); p=0.15). The time taken for successful insertion was similar (58 (12-241) vs 54 (10-281); p=0.30). 9.4% and 10.8% of women required additional methods of cervical ripening. More women in the speculum group (41.7% vs 33.2%; P=0.06) felt a medium level of discomfort than digital group. ConclusionInsertion failure and insertion-related pain in the digital approach were comparable to the speculum-guided approach for transcervical Foley catheter insertion in primigravida for cervical ripening. Nevertheless, maternal satisfaction was higher in the digital group due to a lesser level of discomfort.