Applying tension to transcervical Foley balloon fails to reduce delivery time or improve secondary outcomes: Study

Recent research paper aimed to investigate the impact of applying tension to a transcervical Foley balloon on delivery time in term nulliparous patients undergoing labor induction. A cluster randomized clinical trial was conducted, including 279 term nulliparous women undergoing labor induction with transcervical Foley balloon placement. Participants were assigned to either the tension or no-tension group on a randomized, weekly basis. The primary outcome measured was the time from initial Foley balloon insertion to delivery, with secondary outcomes including cesarean delivery rates, peripartum infection, and neonatal intensive care unit admission.

Study Findings

The study found that applying tension to a transcervical Foley balloon did not significantly reduce delivery time or improve secondary outcomes. The median time from Foley placement to delivery was 1,596 minutes for the tension group and 1,621 minutes for the no-tension group, with no significant differences in secondary outcomes such as cesarean delivery rates, peripartum infection, and neonatal intensive care unit admission.

Research Methodology

The research methodology included a pragmatic cluster randomized clinical trial, with a waiver of informed consent, randomization based on weekly clusters, and inclusion and exclusion criteria to ensure the study's robustness and generalizability. The study's large sample size of 279 participants increased the ability to detect significant differences in outcomes between the tension and no-tension groups compared with prior smaller studies. The study also examined a comprehensive range of primary and secondary outcomes in the intention-to-treat and per-protocol populations, providing valuable insights.

Study Limitations

However, the study had limitations, including being conducted at a single institution and not allowing blinding of clinicians or patients to the intervention. Furthermore, the study did not investigate the effects of other variations on Foley balloon use, such as the type of balloon, the method of placement, or the use of concomitant ripening agents, which may influence the effectiveness of the method for cervical ripening and labor induction.

In conclusion, the study found no significant difference in delivery times or secondary outcomes between the tension and no-tension groups when using a transcervical Foley balloon for cervical ripening in nulliparous women undergoing labor induction. The findings suggest that applying tension to the transcervical Foley balloon may not have a clear advantage or disadvantage. The paper also highlighted the need for further research to identify the most effective strategies for cervical ripening and labor induction, considering the high rate of labor induction in the United States and the significant variation in clinical practice.

Key Points -

- The study findings revealed that applying tension to a transcervical Foley balloon did not significantly reduce delivery time or improve secondary outcomes. The median time from Foley placement to delivery was 1,596 minutes for the tension group and 1,621 minutes for the no-tension group, with no significant differences in secondary outcomes such as cesarean delivery rates, peripartum infection, and neonatal intensive care unit admission.

- The research methodology included a pragmatic cluster randomized clinical trial, with a waiver of informed consent, randomization based on weekly clusters, and inclusion and exclusion criteria to ensure the study's robustness and generalizability. The study's large sample size of 279 participants increased the ability to detect significant differences in outcomes between the tension and no-tension groups compared with prior smaller studies. The study also examined a comprehensive range of primary and secondary outcomes in the intention-to-treat and per-protocol populations, providing valuable insights. However, the study had limitations, including being conducted at a single institution and not allowing blinding of clinicians or patients to the intervention. Furthermore, the study did not investigate the effects of other variations on Foley balloon use, such as the type of balloon, the method of placement, or the use of concomitant ripening agents, which may influence the effectiveness of the method for cervical ripening and labor induction.

Reference –

Benson, Meagan DO; Younes, Lena MD; Watson, Alisha MD; Saade, George R. MD; Saad, Antonio F. MD. Applying Tension to the Transcervical Foley Balloon and Delivery Times in Term Nulliparous Women Undergoing Induction of Labor: A Randomized Controlled Trial. Obstetrics & Gynecology 143(5):p 670-676, May 2024. | DOI: 10.1097/AOG.0000000000005546