Clinical Characteristics of the Controlled-Release Dinoprostone Vaginal Delivery System (PROPESS).

Abstract

Adequate cervical ripening is essential before labor induction. However, effective methods for cervical ripening are limited in Japan. Although the controlled-release dinoprostone vaginal delivery system (PROPESS) was approved in Japan in 2020, it has not gained widespread acceptance over traditional methods. This observational study aimed to analyze the characteristics and precautions of the PROPESS based on cases of administration for cervical ripening conducted at five hospitals in the Mie Prefecture, Japan, between April 2020 and September 2021. We retrospectively evaluated cases wherein PROPESS was used for cervical ripening to determine its clinical characteristics. A total of 123 pregnant women were included in this study. The most common reason for PROPESS device removal was painful regular uterine contractions within 3 min after administration. Among these women, 48.5% had PROPESS removed within 4 h after administration. PROPESS removal due to non-reassuring fetal status occurred in 12 of the 123 (9.8%) women, with removal occurring within 4 h after administration in 8 of these cases. Among these eight cases, four (50.0%) had accompanying uterine hyperstimulation. The peak time from PROPESS administration to vaginal delivery was 28-32 h for primiparas and 4-8 h for multiparas. This study provides a comprehensive overview of PROPESS usage, highlighting the need for strict monitoring within 4 h after PROPESS administration to ensure its safety. This study provides valuable insights for facilities in Japan planning to implement the PROPESS in the future.