Prostaglandina E 2 intracervical (Prepidil) frente a dispositivo vaginal (Propess) en la maduración cervical e inicio del parto. Estudio comparativo

Abstract

Objective To compare the efficacy and safety of prostaglandin E 2 (PGE 2) intracervical gel (Prepidil) with that of PGE2 vaginal insert (Propress) in cervical ripening and labor induction. Material and methods Two hundred pregnant women with unfavorable Bishop's scores (<6) requiring induction of labor were selected through nonprobabilistic sampling of consecutive cases. All the women were treated with PGE 2. One-hundred pregnant women received an intracervical PGE 2 dose, which was repeated 24 and 48 hours later if the cervix remained unfavorable. If labor was not induced 48 hours after the initial dose, amniotomy was performed and oxytocin was administered. The same procedures were performed in another 100 women who were administered PGE 2 through a vaginal insert. The characteristics of the pregnant women,the number of applications, the interval between the applications and the beginning of labor, type of delivery, perinatal outcomes, and adverse effects were evaluated. For the statistical comparison of results, the SPSS 10.0 statistical package was used. Values of p < 0.05 were considered significant. Results The patients’ characteristics were similar, allowing exact comparisons. Active labor began after the first application of PGE 2 in 76% of the patients treated with intracervical gel compared with 78% of those with the vaginal insert. Both procedures proved to be more effective in multiparas than in nulliparas. The interval between PGE 2 application and the beginning of labor was less than 12 hours in 55% of the roup with intracervical gel compared with 40% of the group with the vaginal insert. Nevertheless, the mean interval between the two procedures showed minimal differences: 17.06 hours for the gel and 18.46 hours for the vaginal device. With both procedures, this interval was lower in multiparas than in nulliparas (10.82 hours versus 15.40 hours). The rate of caesarean section was 27% in women with intracervical gel and 24% in those with the vaginal device. This difference was not statistically significant. Five percent of cesarean sections were performed for failure of induction in the group with intracervical gel compared with 3% in the group with the vaginal device. A second application was associated with a higher rate of caesarean section; the highest percentage was found in the group treated with intracervical gel, with statistically significant differences (p < 0.005). With both procedures, cesarean section was more frequent in nulliparas than in multiparas, with statistically significant differences in the vaginal insert group; however, in the intracervical gel group these differences did not reach statistical significant due to the small number of multiparas in this group. No significant differences were found between the two groups in perinatal outcomes or adverse effects. Conclusion Both forms of PGE 2 are safe and effective, although the vaginal insert was associated with a lower rate of caesarean section when a second application was required. This finding could be related to the lower rate of cesarean section for failure of induction and to the higher parity in the vaginal insert group. In view of these results and the ease of placement and withdrawal of the vaginal device, this alternative is a valid option for cervical ripening and labor induction.