Suya Kang, Liping Zhou, Li-ping Zhu, Yun Wang, Yongfei Yue, Li-ping Yan
{"title":"卡贝托星与催产素预防高危妇女选择性剖宫产术后产后出血的前瞻性、随机、开放标签对照试验","authors":"Suya Kang, Liping Zhou, Li-ping Zhu, Yun Wang, Yongfei Yue, Li-ping Yan","doi":"10.31083/j.ceog4901023","DOIUrl":null,"url":null,"abstract":"Background: To evaluate the efficacy and safety of carbetocin compared with oxytocin for prevention of postpartum hemorrhage (PPH) after elective cesarean section in Chinese high risk women. Methods: This was a single-center, prospective, randomized, open-label, controlled trial recruiting 852 pregnant women with one or more PPH risk factors between April 2017 and August 2019. Pregnant woman who was scheduled for an elective cesarean section were randomly assigned to receive carbetocin or oxytocin for prevention of PPH. The primary efficacy endpoint was the proportion of additional uterotonics. Results: A total of 852 pregnant women were randomly assigned to receive carbetocin (n = 442) or oxytocin (n = 410). The baseline characteristics were comparable between the two groups. The carbetocin group had lower proportion of requiring additional uterotonics (18.4% vs. 24.4%, p = 0.03 in full analysis set [FAS] analysis) to the oxytocin group. The amount of blood loss (intrapartum or postpartum) was no statistically significant difference (all p > 0.05). There were no significant differences in the postpartum hemoglobin, rate of hemostatics, blood transfusion, additional surgical interventions or uterine massage between the two groups. The rates of mild asphyxia in carbetocin and oxytocin groups were 2.1% and 1.3%, respectively. No other poor maternal and neonatal outcomes were observed in two groups. Conclusions: Carbetocin required lower rate of additional uterotonics than oxytocin for prevention of PPH after elective cesarean section in Chinese high risk women. Carbetocin was comparable to oxytocin in postpartum blood loss, postpartum hemoglobin, hemostatics, blood transfusion, additional surgical interventions or uterine massage.","PeriodicalId":10312,"journal":{"name":"Clinical and experimental obstetrics & gynecology","volume":null,"pages":null},"PeriodicalIF":0.4000,"publicationDate":"2022-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"3","resultStr":"{\"title\":\"Carbetocin versus oxytocin for the prevention of postpartum hemorrhage after elective caesarean section in high risk women: a prospective, randomized, open-label, controlled trial in China\",\"authors\":\"Suya Kang, Liping Zhou, Li-ping Zhu, Yun Wang, Yongfei Yue, Li-ping Yan\",\"doi\":\"10.31083/j.ceog4901023\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background: To evaluate the efficacy and safety of carbetocin compared with oxytocin for prevention of postpartum hemorrhage (PPH) after elective cesarean section in Chinese high risk women. Methods: This was a single-center, prospective, randomized, open-label, controlled trial recruiting 852 pregnant women with one or more PPH risk factors between April 2017 and August 2019. Pregnant woman who was scheduled for an elective cesarean section were randomly assigned to receive carbetocin or oxytocin for prevention of PPH. The primary efficacy endpoint was the proportion of additional uterotonics. Results: A total of 852 pregnant women were randomly assigned to receive carbetocin (n = 442) or oxytocin (n = 410). The baseline characteristics were comparable between the two groups. The carbetocin group had lower proportion of requiring additional uterotonics (18.4% vs. 24.4%, p = 0.03 in full analysis set [FAS] analysis) to the oxytocin group. The amount of blood loss (intrapartum or postpartum) was no statistically significant difference (all p > 0.05). There were no significant differences in the postpartum hemoglobin, rate of hemostatics, blood transfusion, additional surgical interventions or uterine massage between the two groups. The rates of mild asphyxia in carbetocin and oxytocin groups were 2.1% and 1.3%, respectively. No other poor maternal and neonatal outcomes were observed in two groups. Conclusions: Carbetocin required lower rate of additional uterotonics than oxytocin for prevention of PPH after elective cesarean section in Chinese high risk women. Carbetocin was comparable to oxytocin in postpartum blood loss, postpartum hemoglobin, hemostatics, blood transfusion, additional surgical interventions or uterine massage.\",\"PeriodicalId\":10312,\"journal\":{\"name\":\"Clinical and experimental obstetrics & gynecology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.4000,\"publicationDate\":\"2022-01-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"3\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical and experimental obstetrics & gynecology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.31083/j.ceog4901023\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and experimental obstetrics & gynecology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.31083/j.ceog4901023","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
Carbetocin versus oxytocin for the prevention of postpartum hemorrhage after elective caesarean section in high risk women: a prospective, randomized, open-label, controlled trial in China
Background: To evaluate the efficacy and safety of carbetocin compared with oxytocin for prevention of postpartum hemorrhage (PPH) after elective cesarean section in Chinese high risk women. Methods: This was a single-center, prospective, randomized, open-label, controlled trial recruiting 852 pregnant women with one or more PPH risk factors between April 2017 and August 2019. Pregnant woman who was scheduled for an elective cesarean section were randomly assigned to receive carbetocin or oxytocin for prevention of PPH. The primary efficacy endpoint was the proportion of additional uterotonics. Results: A total of 852 pregnant women were randomly assigned to receive carbetocin (n = 442) or oxytocin (n = 410). The baseline characteristics were comparable between the two groups. The carbetocin group had lower proportion of requiring additional uterotonics (18.4% vs. 24.4%, p = 0.03 in full analysis set [FAS] analysis) to the oxytocin group. The amount of blood loss (intrapartum or postpartum) was no statistically significant difference (all p > 0.05). There were no significant differences in the postpartum hemoglobin, rate of hemostatics, blood transfusion, additional surgical interventions or uterine massage between the two groups. The rates of mild asphyxia in carbetocin and oxytocin groups were 2.1% and 1.3%, respectively. No other poor maternal and neonatal outcomes were observed in two groups. Conclusions: Carbetocin required lower rate of additional uterotonics than oxytocin for prevention of PPH after elective cesarean section in Chinese high risk women. Carbetocin was comparable to oxytocin in postpartum blood loss, postpartum hemoglobin, hemostatics, blood transfusion, additional surgical interventions or uterine massage.
期刊介绍:
CEOG is an international, peer-reviewed, open access journal. CEOG covers all aspects of Obstetrics and Gynecology, including obstetrics, prenatal diagnosis, maternal-fetal medicine, perinatology, general gynecology, gynecologic oncology, uro-gynecology, reproductive medicine, infertility, reproductive endocrinology, sexual medicine. All submissions of cutting-edge advances of medical research in the area of women''s health worldwide are encouraged.