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5: Induction of labor at term: a comparison of Foley catheter and prostaglandins (trial registration NTR 1646)

      Objective

      To assess the effectiveness of a transcervical Foley catheter as compared to prostaglandins for induction of labor in term women with an unfavorable cervix.

      Study Design

      A multicentre randomized controlled trial was conducted in 12 hospitals in the Netherlands between February 2009 and May 2010. Women with a singleton pregnancy in cephalic presentation at term and an unfavorable cervix (Bishop score < 6) scheduled for induction of labor were randomly allocated to either induction with a 30 cc transcervical Foley catheter or vaginal prostaglandin E2 gel. The primary outcome was cesarean section rate. Secondary outcomes included time to delivery and maternal and neonatal morbidity. Analysis was intention to treat. To demonstrate a reduction in cesarean section rate from 25% to 17% (α error 5%, β error 20%) two groups of 406 women were needed.

      Results

      We included 824 women who were equally assigned to Foley catheter or prostaglandin E2 gel. Cesarean section rates were comparable in both groups (22% vs. 19%, RR 1.15, 95% CI .86-1.5). The median time (IQR) (hours) from start of induction to delivery was 29 (15-36) in the Foley group and 17 (6-33) in the prostaglandin group (p=0.001).Umbilical cord pH <7.05 was seen significantly less often in the Foley group. Other secondary outcomes are outlined in the table.
      Tabled 1
      FoleyProstaglandinRR (95% CI)
      Cesarean section22%19%1.2 (.86-1.5)
       Fetal distress7.3%8.7%.85 (.51-1.4)
       Failure to progress13%8.4%1.6 (1.0-2.4)
      5 min. Apgar Score <7.60%2.0%.29 (.06-1.4)
      Umbilical cord pH <7.051.9%5.2%.36 (.13-.99)
      Neonatal admission due to suspected infection4.8%6.4%.75 (.41-1.4)
      other reason23%27%.83 (.64-1.1)
      Neonatal sepsis.80%1.1%.76 (.17-3.4)
      Maternal fever (<38°C) during labor3.1%3.9%.80 (.37-1.7)
      Maternal infection post partum (endometritis, wound infection, UTI).80%2.2%.38 (.10-1.4)
      Uterine hyperstimulation2.0%3.1%.65 (.25-1.7)
      Post partum hemorrhage (>1000cc)6.0%9.6%.62 (.37-1.1)

      Conclusions

      In term women with an unfavorable cervix induction of labor with a Foley catheter is equally effective as induction with prostaglandins with less morbidity, but a longer time to delivery.