DOI: 10.1097/md.0000000000049320 ISSN: 0025-7974

Digital versus speculum insertion of Foley catheter for cervical ripening: A systematic review and meta-analysis of randomized controlled trials

Jun Zhou, Huihao Zhou, Qian Chen, Jingui Xu
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Background:

To compare the efficacy and safety of digital and speculum-guided transcervical Foley catheter insertion for cervical ripening.

Methods:

Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines, a comprehensive search of PubMed, Embase, Cochrane CENTRAL, Web of Science, and ClinicalTrials.gov was conducted from database inception through October 2025. Randomized controlled trials comparing digital with speculum-guided transcervical Foley catheter insertion in term singleton pregnancies were eligible. The primary outcomes encompassed maternal pain assessment scores and catheter insertion duration. The methodological quality of the included studies was appraised in accordance with the Cochrane Risk of Bias 2.0 framework. Statistical analyses were performed with RevMan 5.3. Heterogeneity was quantified using the I 2 statistic. Dichotomous outcomes were reported as relative risk with 95% confidence intervals (CI), and continuous outcomes as mean difference. The certainty of evidence was graded using Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology.

Results:

Five randomized controlled trials including 1046 women met inclusion criteria. Digital insertion was not associated with reduced procedural pain compared with speculum-guided insertion (MD 0.54; 95% CI −1.89 to 2.97; I 2  = 97%). Insertion time did not differ significantly between the 2 techniques (MD −0.32; 95% CI −1.06 to 0.41; I 2  = 85%). No significant differences were observed in induction-to-delivery interval, cesarean delivery rate, need for additional ripening methods, or maternal and neonatal adverse outcomes.

Conclusion:

Digital transcervical Foley catheter insertion demonstrates procedural efficiency and obstetric safety equivalent to speculum-guided techniques.

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