[An open evaluation of prolonged-release dinoprostone with a retrieval system (a formulation of 1.1 MM) in unfavorable cervical ripening in the induction of labor for medical and obstetrical indications].

An open prospective study was carried out in order to evaluate controlled-release dinoprostone pessary with retrieval system in 40 patients. The objective of the study was to obtain clinical experience in Mexico and to assess its efficacy and safety during use. The following results were obtained. The Bishop Score before treatment was 2.98 +/- 1.23, and after treatment it was 8.33 +/- 2.81. The difference was significant (P = 0.0001). Twenty-five patients (62.5%) had spontaneous vaginal delivery, and 14 patients (35%) underwent caesarean section. The indications for the withdrawal of the pessary were as follow: start of labor in 19 patients (47.5%), completation of observation period in 17 patients (42.5%), maternal complications in 2 patients (5%) and, maternal and fetal complications in 2 patients (5%). The mean time between pessary insertion and withdrawal was 8.52 hours; the mean time to start of labor was 10:17 hours; the mean time to start of the 2 degrees labor period was 16:25 hours. The mean duration of labor in all 40 patients was 8:48 hours. We conclude that this study confirms the efficacy of controlled-release dinoprostone with retrieval system in cervical ripening, being easy to insert and to withdraw, and well tolerated since adverse events only occurred in 10% of all patients (uterine hyperstimulation and fetal tachycardia which were controlled by merely withdrawing the pessary). Only one patient (2.5%) required beta-mimetic support in order to control the induced uterine hyperstimulation.