Risk of Intra-Amniotic Infection After Cervical Ripening Balloon for Prelabor Rupture of Membranes

OBJECTIVE: To estimate the odds of intra-amniotic infection among individuals with prelabor rupture of membranes (PROM) who underwent labor induction with a cervical ripening balloon, compared with the odds of infection from a pharmacologic method, by performing a systematic review and meta-analysis. DATA SOURCES: MEDLINE through the PubMed interface, EMBASE, Web of Science, Cochrane Library, and ClinicalTrials.gov were searched for studies that evaluated intra-amniotic infection among individuals with PROM who were induced with a cervical ripening balloon compared with induction with oxytocin, prostaglandin, or some combination thereof. METHODS OF STUDY SELECTION: Two reviewers independently screened studies, extracted data, and assessed study quality. Odds ratios (OR) with 95% CIs were pooled using a randoms effect model. TABULATION, INTEGRATION, AND RESULTS: Fourteen studies, eight randomized controlled trials (RCTs), and six retrospective cohort studies, which included 2,165 participants, met inclusion criteria; 1,074 participants underwent the cervical ripening balloon and 1,091 received pharmacologic agents. Studies included deliveries that occurred in 2002 through 2023. Six studies were from the United States, three from France, two from Finland, and one each from Iran, the Netherlands, and Sweden. The pooled weighted rate of intra-amniotic infection was 9.4% (95% CI, 5.9–13.6%) with cervical ripening balloon and 7.0% (95% CI, 4.4–10.2%) with pharmacologic methods (OR 1.46; 95% CI, 0.90–2.37; I 2 45%). In analyses restricted to RCTs, cervical ripening balloon was associated with increased intra-amniotic infection (OR 1.84; 95% CI, 1.03–3.28; I 2 0%), whereas no association was observed in cohort studies (OR 1.25; 95% CI, 0.50–3.13; I 2 68%). Rates of intra-amniotic infection were similar between cervical ripening balloon and prostaglandin (OR 1.27; 95% CI, 0.60–2.70; I 2 54%) and were similar between cervical ripening balloon and oxytocin (OR 1.66; 95% CI, 0.74–3.75; I 2 22%). Among studies assessed as a low risk of bias, cervical ripening balloon was associated with higher odds of intra-amniotic infection than pharmacologic methods (OR 1.74; 95% CI, 1.01–3.01; I 2 30%). CONCLUSION: Overall intra-amniotic infection odds were similar between cervical ripening balloon and a pharmacologic induction among individuals with PROM. However, analysis limited to RCTs and low risk of bias studies suggests an association between cervical ripening balloon use and increased intra-amniotic infection. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD420251085355.