Outcomes of mifepristone usage for cervical ripening and induction of labour in full-term pregnancy: Randomized controlled trial
European Journal of Obstetrics & Gynecology and Reproductive Biology Sep 12, 2017
Baev OR, et al. - The effectiveness and safety of mifepristone use for cervical ripening and induction of labour versus expectant management in full-term pregnancy were assessed in this study. It was concluded that the mifepristone was efficient on inducing cervical ripening and labour in full-term pregnancy. No major difference was seen 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 associated with the mifepristone action.
Methods
- For this study, they designed a randomized controlled trial.
- In this study, a total of 149 women were randomized, 74 for cervical ripening and induction with mifepristone (200 mg orally at the moment of enrollment and, if applicable, second dose after 24 hours), 75 - expectant management.
- Primary outcomes: gain in Bishop Score within 24 and 48-h of mifepristone; the number of women going into spontaneous labor within 24, 48 and 72-h of mifepristone; the 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 48 hour 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 72 hours 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 ± 1.86 days (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.
- No differences were observed in the mode of delivery, requirement of oxytocin augmentation and main neonatal outcomes.
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