Transcervical Foley's catheter versus Cook balloon for cervical ripening in stillbirth with a scarred uterus: a randomized controlled trial

Abstract

Objective: To compare the efficacy and safety of the use of transcervical Foley's catheter versus Cook cervical ripening balloon in pregnant women with stillbirth, unfavorable cervix and scarred uterus.

Design: Randomized controlled study.

Setting: El Minia University Hospital, El Minia, Egypt.

Patients and methods: Two-hundred pregnant women with stillbirth, unfavorable cervix and scarred uterus were recruited into this study. They were randomized into two groups. In group I (n = 100), cervical ripening was done using Foley's catheter. In group II (n = 100), cervical ripening was done using Cook cervical ripening balloon.

Main outcome measures: Balloon insertion to delivery interval, successful ripening rate, cesarean delivery rate, maternal adverse events and maternal satisfaction.

Results: Time from balloon insertion to expulsion and from balloon insertion to delivery was significantly shorter in Foley's catheter group. However, the difference between the two groups regarding time from balloon insertion to active labor, time from balloon expulsion to delivery, cervical ripening, cesarean section, instrumental delivery, pain score, need for analgesia, hospital stay and maternal satisfaction was not statistically significant.

Conclusions: Foley's catheter and Cook cervical ripening balloon are comparable regarding efficacy and safety profile when used to ripen the cervix in pregnant women with stillbirth, unfavorable cervix and scarred uterus. However, Foley's catheter has a shorter induction to delivery interval and is relatively cheaper device.

Keywords: Cervical ripening; Cook balloon; Foley catheter; scarred uterus; stillbirth.