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Cervical ripening balloon with and without oxytocin in multiparas: a randomized controlled trial

      Background

      The optimal method for induction of labor for multiparous women with an unfavorable cervix is unknown.

      Objective

      We sought to determine if induction of labor with simultaneous use of oxytocin and a cervical ripening balloon, compared with sequential use, increases the likelihood of delivery within 24 hours in multiparous women.

      Study Design

      We performed a randomized controlled trial from November 2014 through June 2017. Eligible participants were multiparous women with a vertex presenting, nonanomalous singleton gestation ≥34 weeks undergoing induction of labor. Women were excluded for admission cervical examination >2 cm, ruptured membranes, chorioamnionitis or evidence of systemic infection, placental abruption, low-lying placenta, >1 prior cesarean delivery, or contraindication to vaginal delivery. Patients were randomly allocated to the following cervical ripening groups: simultaneous (oxytocin with cervical ripening balloon) or sequential (oxytocin following cervical ripening balloon expulsion). The primary outcome was delivery within 24 hours of cervical ripening balloon placement. Secondary outcomes included induction-to-delivery interval, time to cervical ripening balloon expulsion, mode of delivery, and adverse maternal or neonatal outcomes.

      Results

      In all, 180 patients were randomized (90 simultaneous, 90 sequential). Baseline demographic and obstetric characteristics were similar between study groups. Women in the simultaneous group were significantly more likely to deliver within 24 hours of cervical ripening balloon placement compared to the sequential group (87.8% vs 73.3%, P = .02). The simultaneous group also had a significantly shorter induction-to-delivery interval and greater cervical dilation at cervical ripening balloon expulsion. There were no differences in mode of delivery, chorioamnionitis, or adverse maternal or neonatal outcomes.

      Conclusion

      In multiparous women with an unfavorable cervix, the simultaneous use of cervical ripening balloon and oxytocin results in an increased frequency of delivery within 24 hours and a shorter induction-to-delivery interval.

      Key words

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      Linked Article

      • Vaginal delivery within 24 hours of labor induction as a primary outcome: what's the rush?
        American Journal of Obstetrics & GynecologyVol. 219Issue 5
        • Preview
          We have read with great interest the report of Bauer et al1 that compared the likelihood of delivery within 24 hours in multiparous women by labor induction with simultaneous vs sequential use of oxytocin and a cervical ripening balloon. Although meticulously performed and clinically important, this article evokes a pivotal issue. Not uncommonly, parturients describe the feeling that the medical personnel were in a hurry during the delivery, as trying to “clear the room” by performing unnecessary procedures, such as episiotomies, operative vaginal deliveries, or even cesarean deliveries.
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        American Journal of Obstetrics & GynecologyVol. 219Issue 5
        • Preview
          We would like to thank Drs Sagi-Dain and Sagi for their thoughtful response to our study. We elected to use labor induction-delivery, rather than vaginal delivery, within 24 hours as our primary outcome because we assumed that, within a multiparous patient population, the majority of patients would have vaginal deliveries. Additionally, at the outset of an induction of labor, it is impossible to know who will attain a vaginal delivery and who will require cesarean delivery. Based on these assumptions, we used data from the initial trial by Pettker et al1 to power our analysis.
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