Digital vs speculum–guided catheter balloon insertion for cervical ripening in multiparas: a randomized controlled trial

BACKGROUND: Catheter balloon insertion into the maternal uterine cervix is routinely speculum guided; digital insertion has been reported, but it was not found to be more tolerable among nulliparas. OBJECTIVE: In a cohort of multiparas, we aimed to evaluate maternal pain, the induction to delivery interval, and maternal satisfaction with digital insertion vs speculum-guided placement of a Foley catheter balloon for labor induction. STUDY DESIGN: This randomized trial was conducted at a single, tertiary, university-affiliated hospital. The participants were multiparas (parity ≥1) and were admitted at term for labor induction with a Bishop score <6. They were randomized to 2 groups, namely the digital insertion and the speculum–guided Foley catheter insertion groups. An intention-to-treat analysis was performed. The co-primary outcomes were visual analog scale scores (0–10) and induction to delivery intervals. Secondary outcomes were procedure duration, maternal satisfaction, cervical ripening (Bishop score ≥6), delivery within 24 hours, infection rate, and neonatal outcomes. RESULTS: A total of 50 women were analyzed for each study group. For the digitally inserted vs speculum–guided insertion group, the median visual analog scale score at catheter insertion was lower (4; range, 0–10; vs 7; range, 0–10; P<.001), and the induction to delivery interval was similar. For the digitally inserted vs speculum–guided insertion group, the median maternal satisfaction score was greater (5; range 3–5; vs 4; 1–5; P=.01), and the median procedure duration was shorter (2.1; range, 1.4–5.3 minutes vs 3.0; range, 1.4–5.0; P<.001). In the multivariate analysis, digital insertion (P=.009) and increased parity (P=.001) independently decreased the visual analog scale score. Cervical ripening, the maternal infection rate, and the neonatal outcomes did not differ significantly between the groups. CONCLUSION: Digital insertion of a Foley catheter balloon for cervical ripening in multiparas is less painful and quicker than speculum-guided insertion. It is also not inferior in terms of successful cervical ripening.