462: Balloon catheter for induction of labor with or without tension applied: a randomized controlled trial

ObjectiveTo determine whether tension placed to a transcervical balloon catheter inserted for induction of labor results in faster times to delivery.Study DesignThis is a prospective, randomized controlled trial. 66 women with singleton gestations being induced (Bishop score = 6) with a balloon catheter were randomized to applied tension or no tension. Manual tension was applied to the catheter which was then secured to the thigh and tension was replaced in 30 minute increments. There were 36 patients in the tension group and 30 controls (no tension). Low dose oxytocin (max 6 milliunits/min) was administered after catheter placement. The primary outcome was time from insertion to delivery. A secondary outcome was time from insertion to catheter expulsion. Differences between groups in obstetric data and maternal/neonatal outcomes were assessed using independent student t tests, Kolmogorov-Smirnov tests, chi-square tests, and Fisher's Exact tests. Survival analysis using lifetables was used to adjust for differential length of follow-up between the two groups from time of catheter insertion to delivery and from time of insertion to expulsion. A p value of <0.05 was set as significant.ResultsResults are summarized in Figs. 1 and 2. There were no statistically significant differences between the two groups with respect to ethnicity, parity, maximum pain score during catheter use, epidural use, histologic chorioamnionitis, and Apgar scores. The median cumulative time from catheter insertion to delivery between the tension group and the no tension group was 16.3 hours vs 17.5 hours (p=0.35, Fig. 2). The median cumulative time from catheter insertion to expulsion was significantly less in the tension group (2.2 hours vs 3.8 hours, p<0.01, Fig. 2).ConclusionView Large Image Figure ViewerDownload Hi-res image Download (PPT) ObjectiveTo determine whether tension placed to a transcervical balloon catheter inserted for induction of labor results in faster times to delivery. To determine whether tension placed to a transcervical balloon catheter inserted for induction of labor results in faster times to delivery. Study DesignThis is a prospective, randomized controlled trial. 66 women with singleton gestations being induced (Bishop score = 6) with a balloon catheter were randomized to applied tension or no tension. Manual tension was applied to the catheter which was then secured to the thigh and tension was replaced in 30 minute increments. There were 36 patients in the tension group and 30 controls (no tension). Low dose oxytocin (max 6 milliunits/min) was administered after catheter placement. The primary outcome was time from insertion to delivery. A secondary outcome was time from insertion to catheter expulsion. Differences between groups in obstetric data and maternal/neonatal outcomes were assessed using independent student t tests, Kolmogorov-Smirnov tests, chi-square tests, and Fisher's Exact tests. Survival analysis using lifetables was used to adjust for differential length of follow-up between the two groups from time of catheter insertion to delivery and from time of insertion to expulsion. A p value of <0.05 was set as significant. This is a prospective, randomized controlled trial. 66 women with singleton gestations being induced (Bishop score = 6) with a balloon catheter were randomized to applied tension or no tension. Manual tension was applied to the catheter which was then secured to the thigh and tension was replaced in 30 minute increments. There were 36 patients in the tension group and 30 controls (no tension). Low dose oxytocin (max 6 milliunits/min) was administered after catheter placement. The primary outcome was time from insertion to delivery. A secondary outcome was time from insertion to catheter expulsion. Differences between groups in obstetric data and maternal/neonatal outcomes were assessed using independent student t tests, Kolmogorov-Smirnov tests, chi-square tests, and Fisher's Exact tests. Survival analysis using lifetables was used to adjust for differential length of follow-up between the two groups from time of catheter insertion to delivery and from time of insertion to expulsion. A p value of <0.05 was set as significant. ResultsResults are summarized in Figs. 1 and 2. There were no statistically significant differences between the two groups with respect to ethnicity, parity, maximum pain score during catheter use, epidural use, histologic chorioamnionitis, and Apgar scores. The median cumulative time from catheter insertion to delivery between the tension group and the no tension group was 16.3 hours vs 17.5 hours (p=0.35, Fig. 2). The median cumulative time from catheter insertion to expulsion was significantly less in the tension group (2.2 hours vs 3.8 hours, p<0.01, Fig. 2). Results are summarized in Figs. 1 and 2. There were no statistically significant differences between the two groups with respect to ethnicity, parity, maximum pain score during catheter use, epidural use, histologic chorioamnionitis, and Apgar scores. The median cumulative time from catheter insertion to delivery between the tension group and the no tension group was 16.3 hours vs 17.5 hours (p=0.35, Fig. 2). The median cumulative time from catheter insertion to expulsion was significantly less in the tension group (2.2 hours vs 3.8 hours, p<0.01, Fig. 2). Conclusion