Background: Over the last decade, a lot of clinical reviews have been published, but they are heterogeneous and present disparity of outcomes. The best choice for inducing labor is not clear today. The objective of the study is to compare misoprostol with dinoprostone for labor induction including obstetrical and neonatal outcomes, side effects and costs.
Methods and findings:From September 2012 to December 2013 a retrospective observational study was performed, including all pregnant women with medical indication of induction of labor. Three-hundred ten patients were included: 180 received 25μg of vaginal misoprostol and 130 received 10mg of vaginal dinoprostone. The study groups were similar with regard to age, parity, initial Bishop score and birth weight. Misoprostol group had higher percentage of entering active phase of labor within 24 hours (61.1% versus 45.4%; ORa=2.0 [1.3-3.3]). The cesarean section rate was lower with misoprostol (17.2% versus 24.6%; ORa=0.6 [0.3-1.1]). The Bishop score obtained with misoprostol was more favorable after ripening. The use of epidural analgesia was statistically higher in misoprostol group (81.7% versus 68.5%; ORa=2.4 [1.4-4.2]). The difference in time from the start of induction to delivery and adverse neonatal outcomes were similar in both groups. The hospital stay and the costs of hospital stay were significantly lower with misoprostol (€2690 versus €3152; pa=0.006).
Conclusions:Misoprostol at doses of 25μg is more effective and more cost effective than vaginal dinoprostone, with the same safety in labor induction in women with unfavorable cervix.
P: median for N 8.3 vs. for P 7.2 mo; hazard ratio (HR) adjusted for stratification factors 1.03; 95% confidence interval (CI),[0.71 to 1.48]; p0.879. Median overall survival (85 events) for N 20 vs. for P 22 mo; HR: 1.10; CI: 0.72-1.69; p0.665. Treatment-emerged grade 3-4 adverse events were higher in N vs P arm: liver function tests 13%/0%; diarrhea 12%/6%; neutropenia 21%/14%; asthenia 4%/1%. Patientreported outcomes will be reported. Conclusion* Addition of nintedanib to chemotherapy did not improve PFS nor OS. This regimen cannot be recommended to undergo further testing in a phase III trial.
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