Abstract
Larger volume Foley catheters are occasionally used for labor induction. In some instances the balloon is overinflated to obtain this volume. Neither the risk or rate of rupture are known for this practice. The purpose of this study was to evaluate the use of overinflated Foley catheter balloons and the rate of rupture in prospective trials and to describe rupture events in our institutions. Clinical trials and prospective cohorts were identified through a search of MEDLINE from 2000 through May 1, 2017; prospective studies were examined for the use of overinflated Foley catheters. Reports of overinflated balloons were then reviewed in detail to determine if rupture occurred and to record any reported maternal, neonatal, or gynecologic outcomes. Internal reports to the Obstetric Safety Report System were used to describe the local cases at our institutions. We reviewed 296 abstracts. Seventeen prospective cohorts or randomized trials used larger balloon volumes (≥50 mL), of which 12 abstracts confirmed routine overinflation of the balloon. Within these studies, 19 patients who underwent cervical ripening with overinflated Foley catheters experienced balloon rupture during use. The incidence of rupture in these studies was 0.9%. No adverse maternal or fetal effects were noted. Internal safety reporting yielded an additional case. One gynecologic case was identified internally. The patient had an overinflated Foley catheter balloon used to tamponade excessive uterine bleeding after uterine evacuation. Balloon rupture was noted, and hysteroscopy was needed to remove fragments of the balloon. Overinflation of Foley catheter balloons in obstetric and gynecologic applications may cause rupture. Because of possible underreporting, the extent of complications that may result from balloon rupture is unknown.
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