Résumé
In France, induction of labor (IOL) concerns approximately 26% of term deliveries, with a cervical ripening necessary in over two-thirds of cases. Since 2018, when Angusta® was introduced to the French market, the HAS and FIGO have recommended two dosing regimens for oral misoprostol in labor induction: 25μg every 2 hours or 50μg every 4 hours (up to a maximum of 200μg per 24 hours), without direct comparison of these two regimens. This single-center retrospective study aimed to analyze IOL with Angusta® and compare the efficacy and safety profiles of the two protocols in use since 2022 (25μg/2h versus 50μg/4h) at Montpellier University Hospital. Materials and Methods: patients who received Angusta® for IOL between January 1, 2022, and December 31, 2023, were included. Demographic and obstetric data were collected from the patients' electronic medical records. Descriptive statistics, univariate analysis, multivariate logistic regression analysis and matching procedure were conducted. The primary outcome was delivery within 24 hours after the first dose of Angusta®. Results: this study included 293 patients. Overall, 39.6% of women delivered within 24 hours, with 51% in the 25μg group and 36% in the 50μg group (p=0.02). Nearly 70% of patients went into labor during Angusta® protocol. Among the 44% of patients who did not go into labor within the first 24 hours after starting Angusta®, 33% went into labor during the second cycle. After matching (n=124), the groups no longer differed in terms of delivery within 24 hours (42% vs.39%; p=0.85). More patients in the 25μg group went into labor during the protocol (82% vs. 63%; p=0.02) and received a lower total dose of Angusta® compared to the 50μg group (137.5μg vs. 200μg; p=0.04). There was no difference between the two protocols in terms of delivery mode (20% caesarean section rate; p=1.00) or maternal-fetal complications. Conclusion: Angusta® was an effective method for cervical ripening that did not increase the risk of cesarean sections or maternal-fetal complications. Angusta® protocols 25μg/2h and 50μg/4h demonstrated comparable efficacy and safety. However, patients in the 25μg group consumed a lower total dose and were more likely to go into labor during the ripening process.