Objective: To report complications associated with the use of trans-cervical Foley catheter with extra-amniotic saline infusion (EASI) for cervical ripening.
Methods: This is a retrospective descriptive study of 1,083 women who underwent EASI ripening. Data on perinatal outcome was retrieved from our computerized database and the medical charts. The primary study outcome was the occurrence of side effects related to the procedure.
Results: The study population included 1,083 women. The balloon had to be removed due to complications in 95 (8.8%). The main complications were: acute transient febrile reaction in 32 (3%), non-reassuring fetal heart rate tracing in 22 (2%), vaginal bleeding in 20 (1.8%), unbearable pain that necessitated removal of the catheter in 19 women (1.7%) and altered presentation from vertex to breech in 14 (1.3%).
Conclusion: Complications associated with trans-cervical ripening and EASI occurred in 7.6% and included acute febrile reaction, pain, vaginal bleeding and altered fetal presentation.
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