Abstract
Objective: To assess the efficacy and safety of the dinoprostone vaginal insert compared to repeated prostaglandin administration (including dinoprostone and misoprostol) in women at term. Methods: Electronic databases and additional handsearching were used to identify randomized controlled trial (RCT). We included studies reporting data separately for nulliparous and/or multiparous in women with unfavourable cervix (Bishop <5) and intact membranes. The primary efficacy outcome was caesarean section (CS) rate. Primary safety outcome was uterine hyperstimulation requiring immediate delivery. Results: Eighteen RCTs were eligible and seven studies were included (totally 911 patients). The dinoprostone vaginal insert reduces CS rate in nulliparous women of 24% compared to the other ways of administration (RR = 0.76, 95% CI = 0.59, 0.98). The risk of oxytocin use is reduced with the use of vaginal insert (RR = 0.64, 95% CI = 0.42, 0.99). The risk of hyperstimulation is statistically higher in nulliparous women using vaginal insert than the other ways of administration with RR = 2.17, 95% CI = 1.08,4.33. Conclusions: In nulliparous women with unprepared cervix and intact membranes vaginal insert perform better than repeated vaginal doses since it is associated with more vaginal deliveries and less oxytocin use. Although vaginal insert is associated with more uterine hyperstimulation, it shows a protective effect toward caesarean section.
Declaration of Interest: The study was sponsored by Mother-Infant Dept. Ferring Italy provided a grant for the statistician (CDG).