(83) Application of Tension on Transcervical Foley Catheter for Induction of Labor in Term Nulliparous Women

Objective: To determine whether applying tension to the catheter decreases delivery times in term nulliparous women undergoing pre-induction cervical ripening with a transcervical Foley catheter.

Study Design: This cluster randomized trial included nulliparous patients aged 18 to 49 years with singleton gestation presenting for labor induction with a plan for cervical ripening via transcervical Foley catheter placement. Patients with stillbirth, non-cephalic presentation, prior cesarean, or contraindications for transcervical balloon placement were excluded. Participants were assigned to either the tension or no-tension group based on randomized, weekly clusters (26 total clusters). The primary outcome was the time from initial Foley balloon insertion to delivery. Secondary outcomes included cesarean delivery rates, peripartum infections, and NICU admissions.

Results: 279 subjects were enrolled (138 in the tension and 141 in the no-tension groups). Protocol adherence was 92% in the no-tension and 100% in the tension groups. The baseline characteristics were similar for both groups. In the intent-to-treat population, the median time from Foley placement to delivery was 1596 (range: 430- 3438) minutes for the tension group and 1621 (range: 488-3323) minutes for the no-tension group (p=0.8). Results did not differ in the per-protocol analysis. Similar results were noted for time to vaginal delivery (Table). The Log Rank Mantel-Cox test for time to vaginal delivery after Foley balloon placement demonstrated a hazard ratio of HR 1.1; 95% CI [0.8-1.4]; p = 0.7 (Figure). No significant differences were observed in the secondary outcomes, including the incidence of primary cesarean delivery (34 % vs. 30%, p=0.7), peri-partum infections (36 % vs. 31%, p=0.6), and NICU admissions (10% vs. 10%, p=1) between the two groups

Conclusion: Applying tension to the catheter during pre-induction cervical ripening with a Foley in term nulliparous women does not reduce delivery times or improve outcomes. It is, therefore, appropriate to forgo tension to improve patient satisfaction and facilitate outpatient cervical ripening.