Tugging the Foley catheter balloon every 3 h in nulliparous induction of labor: A randomized controlled trial.

OBJECTIVE

This study evaluates forceful Foley balloon tugging for 30 s 3-hourly to retrieve a comfortably retained balloon compared to usual care (without tugging) during the 12 h of planned passive placement. The primary outcomes were the induction (Foley insertion) to delivery duration and patients' satisfaction.

METHOD: Participants were recruited into a randomized controlled trial in a university hospital in Malaysia from March 2023 to December 2023. Nulliparas admitted for induction of labor by Foley balloon were enrolled. After Foley insertion, participants were randomized to 3-hourly tugging or usual care. Following balloon retrieval (whether tugged out, spontaneously expelled, or at scheduled removal), suitability for amniotomy was assessed by vaginal examination. Follow-on labor induction management was guided by the cervical finding.

RESULTS

A total of 264 patients were randomized, with 132 in each study arm. The primary outcomes of induction to birth duration median [interquartile range] was 33.2 [25.3-43.4] versus 37.2 [27.9-45.8] hours (P = 0.058) and participant satisfaction score (0-10 numerical rating scale [NRS]) with the labor induction process was 9 [7-10] versus 9 [7-10] P = 0.437 for tugging versus usual care, respectively. Secondary outcomes with P < 0.05 were Foley removal as planned at 12 h, Foley displacement after tugging, compliance to protocol, and umbilical artery blood pH. However, pH ≤7.10 was 2/126 (1.6%) versus 3/129 (2.3%) relative risk 0.67 95% CI 0.11-3.95 P > 0.99 for tugging vs. usual care.

CONCLUSION

At nulliparous Foley induction of labor with a planned 12-h ballon placement, tugging the Foley 3-hourly compared to usual care did not expedite birth or increase patient satisfaction.