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Labor

Poster Session 4

(1185) Single-balloon catheter versus Dilapan-S placement for outpatient cervical ripening: A single-blind randomized controlled trial

Wednesday, February 14, 2024
1:00 PM – 2:30 PM  
Location: Prince George's Exhibit Hall CDE, Lower Atrium Level
Objective: To compare Dilapan-S to cervical balloon for outpatient cervical ripening (CR).

Study Design: This was a single-blind, randomized controlled trial at a single tertiary hospital between May 2022 and July 2023. Term patients with no prior c-section and a singleton, vertex fetus scheduled for outpatient CR per hospital policy were eligible. Prior to CR, an NST and exam to confirm Bishop score < 6 were performed. Patients were then consented and randomized to CR catheter with 60mL in the intrauterine balloon or 3 to 5 Dilapan-S hydroscopic dilators then discharged home. Patients returned in 6-24 hours per policy or if clinically indicated. CR agent was removed, blinded exam performed, and patients completed a satisfaction survey. Further induction was per the obstetrical provider. Primary outcome was change in Bishop score. Secondary outcomes included patient satisfaction, time to delivery, mode of delivery, cervical ripening failure (failure to place or need for further ripening) and composite maternal and neonatal morbidity.

Results: 80 patients were randomized with no difference in baseline demographic data, percent nulliparous, starting dilation, or Bishop score. There was no significant difference in change in Bishop score between Dilapan-S and balloon (median change 3 (interquartile range (IQR) 2-5) vs 3 (IQR2-4.5) respectively, p=0.91). There was no difference in time to delivery, mode of delivery or maternal or neonatal outcomes (Table 1). Patients with Dilapan-S were significantly more satisfied with their experience (scale 0-10, median 9(IQR 8-10) vs 8(IQR 5-9), p=0.008) and significantly less likely to experience cervical ripening failure (7(17.5%) vs 15(37.5%), p=0.045) or have unscheduled contact with the medical team (3(7.5%) vs 14(35%);p< 0.01).

Conclusion: Dilapan-S was non-inferior to cervical balloon catheter for outpatient cervical ripening based on change in Bishop score. Patients were significantly more satisfied with Dilapan-S and significantly less likely to experience cervical ripening failure or have unscheduled contact with the medical team compared to single balloon catheter.