Transcervical balloon catheter: no tension needed
Placing tension on a transcervical balloon catheter reduces the time to catheter expulsion but does not hasten time to delivery, according to the results of a recently published randomized controlled clinical trial.1
The single-center prospective study was conducted at St. Mary’s Hospital, Saint Louis University School of Medicine, St Louis, Missouri. It included 140 women with a Bishop score ≤6 and a singleton cephalic gestation who had a balloon catheter (18 French 30 cc Foley bulb) placed with or without tension. Median time from catheter insertion to delivery was analyzed in an intent-to-treat population as the primary outcome, and it was not significantly different between the tension and no tension groups (16.2 hours vs 16.9 hours; P=.814).
Time from catheter insertion to expulsion, which was analyzed as a secondary outcome, was significantly shorter among women who had tension applied to the catheter compared with the no tension group (2.6 hours vs 4.6 hours; P<.001). The results for these 2 endpoints were similar in a per protocol analysis. Other analyses found no significant differences between the tension and no tension groups in the rate of vaginal delivery within 24 hours (79% vs 71%; P=.365) or cesarean delivery rate (25% vs 37%; P=.139].
There were very few complications. The rate of chorioamnionitis was 10.7% overall and not significantly different between the 2 study groups.