Hiroaki Itoh1, Keisuke Ishii2, Naoya Shigeta3, Atsuo Itakura4, Hiromi Hamada5, Takeshi Nagamatsu6, Tomohiko Ishida7, Yasuaki Bungyoku8, Ali Falahati8, Miori Tomisaka8, Mikiya Kitamura8. 1. Department of Obstetrics and Gynecology, Hamamatsu University School of Medicine, Higashi-ku, Hamamatsu, Japan. 2. Osaka Women's and Children's Hospital, Izumi, Japan. 3. Rinku General Medical Center, Izumisanoshi, Osaka, Japan. 4. Juntendo University, Bunkyo-ku, Tokyo, Japan. 5. University of Tsukuba, Tsukuba, Ibaraki, Japan. 6. The University of Tokyo, Bunkyo-ku, Tokyo, Japan. 7. Itabashi Chuo Medical Center, Itabashi-ku, Tokyo, Japan. 8. Ferring Pharmaceuticals Co. Ltd., Minato-ku, Tokyo, Japan.
Abstract
AIM: To evaluate the efficacy and safety of dinoprostone vaginal insert (PROPESS) in pregnant post-term Japanese women requiring cervical ripening. METHODS: This randomized, double-blind, placebo-controlled study included 114 pregnant Japanese women at term (41 weeks of gestation) requiring cervical ripening (baseline Bishop score (BS) ≤ 4). The primary end-point was the proportion of subjects with successful cervical ripening defined as BS ≥ 7 or vaginal delivery in 12 h. The secondary end-points were changes in BS, proportion of women with vaginal delivery, proportion of women receiving mechanical cervical ripening procedure and use of oxytocic drugs. RESULTS: PROPESS administration for a maximum of 12 h showed significantly higher successful cervical ripening rate (47.4% vs 14.3%, respectively; treatment contrast [TC]: 33.1%; P = 0.0002). The median time from administration to vaginal delivery was significantly shorter in the PROPESS group than in the placebo group (26.18 h vs 33.02 h; OR 2.51; 95% CI [1.60-3.92]; P < 0.0001). In the PROPESS group, the dosage of uterotonic drugs, such as oxytocin, decreased, and the number of patients who used these drugs also decreased. CONCLUSION: PROPESS administration for a maximum of 12 h was an effective and well-tolerated treatment for pregnant Japanese women post-term requiring cervical ripening.
RCT Entities:
AIM: To evaluate the efficacy and safety of dinoprostone vaginal insert (PROPESS) in pregnant post-term Japanese women requiring cervical ripening. METHODS: This randomized, double-blind, placebo-controlled study included 114 pregnant Japanese women at term (41 weeks of gestation) requiring cervical ripening (baseline Bishop score (BS) ≤ 4). The primary end-point was the proportion of subjects with successful cervical ripening defined as BS ≥ 7 or vaginal delivery in 12 h. The secondary end-points were changes in BS, proportion of women with vaginal delivery, proportion of women receiving mechanical cervical ripening procedure and use of oxytocic drugs. RESULTS:PROPESS administration for a maximum of 12 h showed significantly higher successful cervical ripening rate (47.4% vs 14.3%, respectively; treatment contrast [TC]: 33.1%; P = 0.0002). The median time from administration to vaginal delivery was significantly shorter in the PROPESS group than in the placebo group (26.18 h vs 33.02 h; OR 2.51; 95% CI [1.60-3.92]; P < 0.0001). In the PROPESS group, the dosage of uterotonic drugs, such as oxytocin, decreased, and the number of patients who used these drugs also decreased. CONCLUSION:PROPESS administration for a maximum of 12 h was an effective and well-tolerated treatment for pregnant Japanese women post-term requiring cervical ripening.
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