Tugging the Foley catheter balloon 3-hourly in multiparous induction of labor: A randomized controlled trial

To retrieve a comfortably retained balloon during the 12 h of planned passive Foley placement, 3-hourly forceful tugging of the Foley for 30 s each time was compared to standard care (no tugging). The primary outcome was the induction (Foley insertion) to delivery interval.

A randomized controlled trial in a university hospital in Malaysia recruited participants from December 2022 to August 2023. Eligible multiparas admitted for induction of labor (IOL) by Foley balloon were recruited. After Foley insertion, patients were randomized to tugging or standard passive care groups during the 12 h of placement. After the Foley balloon had been displaced (through tugging, spontaneous expulsion or as scheduled), standard management was applied, guided by vaginal examination findings.

A total of 220 participants were randomized to two groups, with 110 in each trial arm. The induction to birth interval was (mean ± standard deviation) 27.4 ± 12.3 versus 28.4 ± 11.3 mean difference - 1.0 95% confidence interval (CI) -4.1 to 2.1 h P = 0.536 and induction to vaginal birth interval 26.3 ± 11.8 versus 26.8 ± 10.6 mean difference - 0.6 95% CI -3.9 to 2.8 h P = 0.747 in tugging versus standard care arms, respectively. Cesarean delivery rates were 17/110 (15.5%) versus 28/110 (25.5%; P = 0.138); additional cervical ripening (mainly Foley reinsertion) was carried out for 46/110 (41.8%) versus 53/110 (48.2%; relative risk 0.87, 95% CI 0.85-1.16, P = 0.343), and participants' satisfaction score (0-10 numerical rating scale) was median [interquartile range] 8 [7-9] vs. 8 [7-9] (P = 0.057) in tugging versus standard care arms, respectively.

In multiparous Foley IOL with a planned 12-h balloon placement, compared to standard care, tugging the catheter every 3 h did not hasten birth or affect other secondary outcomes.

This study was registered in the ISRCTN registry on November 24, 2022, with trial identification number ISRCTN 17782392. https://doi.org/10.1186/ISRCTN17782392.