Objective: To compare the safety of keeping an intrauterine Foley catheter for 48 hours versus 24 hours for cervical ripening.
Methods: A randomized controlled trial was conducted at the De Soysa Hospital for Women, Sri Lanka from April 1 to December 31, 2014 (trial registration: SLCTR/2014/006). Low-risk women with a Bishop score ≤5 at 40 weeks + 5 days of gestation were allocated to either 24-hour (n=107; Group A) or 48-hour (n=94; Group B) groups. Proportions developing spontaneous onset of labor (SOL), neonatal status, pre- and post-procedure C-reactive protein (CRP), cervical smears, and placental histology in those who experienced SOL were compared.
Results: In Group A, 35 (32.7%) experienced SOL, against 54 (57.4%) in Group B (P<0.001, odds ratio 2.78, 95% confidence interval 1.56-4.93). There was no difference in mean length of active labor (7.48 vs 7.69 hours), cesarean delivery (16% vs 14%), bacterial vaginosis rates in post-induction cervical smear (10.3% vs 6.7%), mean CRP increase (4.08 vs 3.91 IU), evidence of chorioamnionitis (5.7% vs 11.1%), mean 1 and 5-minute Apgars, number of neonates with pyrexia (8.4 vs 8.5%), and admission to the Special Care Baby Unit (15% vs 12.8%).
Conclusion: Group B experienced a statistically significant increase in SOL, without increasing infectious and neonatal morbidity.
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