To assess the efficacy of transcervical Foley catheter plus oxytocin infusion versus oxytocin infusion alone for labor induction and cervical ripening in women ≥34weeks with PROM.
This is a randomized, multicenter trial of women with a live, singleton gestation ≥34weeks with PROM, an unfavorable cervical exam (≤2cm/80%) and no contraindication to labor. Subjects were randomly allocated to a Foley catheter inflated to 30cc with concurrent oxytocin infusion (FOLEY) or to oxytocin infusion alone. Oxytocin administration was standardized across sites. Block randomization was employed with stratification by parity, term/preterm and hospital site. The primary endpoint was interval from induction to delivery. Secondary outcomes included interval from induction to vaginal delivery, cesarean delivery rate, and maternal and neonatal infectious complications (e.g., clinical and histological chorioamnionitis, endometritis, antibiotic use, and sepsis). Intention-to-treat analysis was performed.
We enrolled 201 women: 93 were allocated to FOLEY and 108 to oxytocin. Demographics were similar between the groups. Linear regression analysis revealed a non-significant shorter time to delivery (-26.6 mins, 95% CI -151.8, 98.5 mins, p = 0.677) in the FOLEY arm as compared to the oxytocin arm. Other delivery outcomes were similar between groups (Table). There were more cases of clinical chorioamnionitis (9.7% vs 2.8%, p = 0.046) in the FOLEY arm as compared to the oxytocin arm. There were no differences for other infectious morbidities or any other variable studied (Table).
Transcervical Foley plus oxytocin infusion does not offer an advantage over oxytocin infusion alone for labor induction in women ≥34weeks with PROM. Additionally, it appears to increase the risk of clinical chorioamnionitis.
© 2016 Published by Elsevier Inc.