A comparison between labor induction with only Dilapan-S and a combination of mifepristone and Dilapan-S in nulliparous women: a prospective pilot study.

OBJECTIVE: The aim of our study was to determine whether the combination of mifepristone and the osmotic dilator Dilapan-S improves the labor induction outcomes as compared to Dilapan-S alone. METHODS: This prospective comparative study included 127 eligible women, of whom 58 underwent cervical ripening with Dilapan-S (12-h exposure, the control group) and 69 with Dilapan-S, with a concurrent pretreatment of 200 mg oral mifepristone (the study group), 8 h before Dilapan-S insertion. RESULTS: The vaginal delivery rate in the control group and the study group was 60.3 and 76.8% (p = .045), respectively; the induction to delivery interval was 22.74 ± 3.01 h and 19,890 ± 2.42 h (p < .001), respectively; and the number of births within 24 h was 43.1 and 73.9% (p < .001), respectively. There was no difference in the rate of failed labor induction (6.9 versus 8.7%, p = .939). The Bishop's score improved significantly after the combined treatment as compared to with Dilapan alone (3.10 ± 0.58 versus 4.03 ± 1.35, p < .001). Moreover, in the study group, labor started earlier and proceeded faster with a lower additional oxytocin usage for labor induction or augmentation. There were no differences in the operative delivery rate and the perinatal outcomes. There were no adverse side effects of both mifepristone and Dilapan-S. CONCLUSION: Our study is the first one to show that in comparison to labor induction using only osmotic dilators Dilapan-S, the combination of mifepristone and Dilapan-S is more efficient in terms of improving cervical ripening and vaginal delivery rate and reducing labor duration and frequency of oxytocin augmentation. The results revealed that this combined method is safe and has no immediate adverse effects on newborns. More studies are needed to evaluate what clinical cases are the most appropriate for the application of this combined method, considering the parity, degree of cervical ripening, and indication for labor induction.

Outcomes of mifepristone usage for cervical ripening and induction of labour in full-term pregnancy. Randomized controlled trial.

OBJECTIVE: The most commonly used approved indications for mifepristone in obstetrics include: termination of early pregnancy, cervical dilatation prior to abortion, labour induction in case of fetal death in utero. Fewer studies have been conducted on the effect of mifepristone on cervical ripening and induction of labour in term pregnancy with a live fetus. The aim of our study was to evaluate efficacy and safety of mifepristone use for cervical ripening and induction of labour versus expectant management in full-term pregnancy. STUDY DESIGN: Randomized controlled trial. 149 women were randomized, 74 for cervical ripening and induction with mifepristone (200mg orally at the moment of enrollment and, if applicable, second dose after 24h), 75 - expectant management. Primary outcomes: gain in Bishop Score within 24 and 48-h of mifepristone; number of women going into spontaneous labor within 24, 48 and 72-h of mifepristone; rate of failed induction or expectant management. SECONDARY OUTCOMES: enrollment-induction to delivery interval; mode of delivery; requirement of oxytocin augmentation, neonatal outcomes. RESULTS: After 48h from enrollment mean gain in Bishop score was 2.58±1.33 in the induction group and 1.15±0.97 in the expectant group (<0.001). Failed management rate was 5.41% and 2.67%, respectively. Significantly more mifepristone treated women had labour within 24, 48 and 72h from enrollment (RR 15.20 CI 95% 2.06-112.18; RR 6.08 CI 95% 2.73-13.57; RR 2.14 CI 95% 1.04-4.42) (p<0.05). Enrollment-induction to delivery interval was significantly shorter in mifepristone group: 2.69±2.06 vs 3.77±1.86days (p<0.001). Premature rupture of membranes, meconium-stained amniotic fluid were more common in expectant management, but regional analgesia and cephalopelvic disproportion - in induction group. There were no differences in mode of delivery, requirement of oxytocin augmentation and main neonatal outcomes. CONCLUSION: Mifepristone was efficient on inducing cervical ripening and labour in full-term pregnancy. There were no significant difference in main maternal and neonatal outcomes between mifepristone use and expectant management. There were no serious adverse side effects of mifepristone, but there were some features of the course of labor, like more painful uterine contractions and trend of higher rate of cephalopelvic disproportion, that might be directly related to the mifepristone action.

Misoprostol Vaginal Insert in Labor Induction: A Cost-Consequences Model for 5 European Countries-An Economic Evaluation Supported with Literature Review and Retrospective Data Collection.

INTRODUCTION: The present study aimed to assess the costs and consequences of using an innovative medical technology, misoprostol vaginal insert (MVI), for the induction of labor (IOL), in place of alternative technologies used as a standard of care. METHODS: This was a retrospective study on cost and resource utilization connected with economic model development. Target population were women with an unfavorable cervix, from 36 weeks of gestation, for whom IOL is clinically indicated. Data on costs and resources was gathered via a dedicated questionnaire, delivered to clinical experts in five EU countries. The five countries participating in the project and providing completed questionnaires were Austria, Poland, Romania, Russia and Slovakia. A targeted literature review in Medline and Cochrane was conducted to identify randomized clinical trials meeting inclusion criteria and to obtain relative effectiveness data on MVI and the alternative technologies. A hospital perspective was considered as most relevant for the study. The economic model was developed to connect data on clinical effectiveness and safety from randomized clinical trials with real life data from local clinical practice. RESULTS: The use of MVI in most scenarios was related to a reduced consumption of hospital staff time and reduced length of patients' stay in hospital wards, leading to lower total costs with MVI when compared to local comparators. CONCLUSIONS: IOL with the use of MVI generated savings from a hospital perspective in most countries and scenarios, in comparison to alternative technologies. FUNDING: Sponsorship, article processing charges, and the open access charge for this study were funded by Ferring Pharmaceuticals Poland.