Maria E. Bekkenes, Marte M. Jørgensen, Anne F. Jacobsen, Morten W. Fagerland, Helene Rakstad-Larsen, Lars Aaberge, Olav Klingenberg, Trude Steinsvik, Lars Asphaug, Leiv Arne Rosseland
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We investigated if carbetocin, a long-acting oxytocin analogue, causes similar changes.</p>\n </section>\n \n <section>\n \n <h3> Design</h3>\n \n <p>Double-blind randomised trial.</p>\n </section>\n \n <section>\n \n <h3> Setting</h3>\n \n <p>University Hospitals, Oslo, Norway.</p>\n </section>\n \n <section>\n \n <h3> Population</h3>\n \n <p>240 singleton pregnant women, 18–50 years, undergoing planned caesarean delivery.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Participants, randomised 1:1, received oxytocin 2.5 IU or carbetocin 100 μg intravenously immediately after delivery.</p>\n </section>\n \n <section>\n \n <h3> Main Outcome Measures</h3>\n \n <p>The primary endpoint was change from baseline in cardiac troponin I (cTnI) serum concentration at 6–10 h postpartum. Secondary endpoints included blood loss, uterine tone (numerical rating scale 0–10), rescue treatment, and healthcare costs 48 h postpartum.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>215 patients underwent a planned caesarean delivery and received their allocated study drug (oxytocin group, <i>n</i> = 112; carbetocin group, <i>n</i> = 103). We detected no difference in median change from baseline cTnI concentration at 6–10 h postpartum (0.0 [95% CI –1.09 to 1.09] ng/L; <i>p</i> = 1.00). Median (interquartile range [IQR]) estimated blood loss was similar: oxytocin, 395 (96 to 627) mL; carbetocin, 335 (127 to 570) mL (group difference: −41 mL [95% CI –158 to 76]; <i>p</i> = 0.49). Rescue treatment utilisation was higher with oxytocin (46.4%) versus carbetocin (27.2%); risk difference. (−19.2% [95% CI –31.2 to −6.3]; <i>p</i> = 0.004). Median (IQR) uterine tone at 5 min after delivery was lower with oxytocin (7 [6 to 8]) versus carbetocin (8 [7 to 9]; group difference 1.0 NRS [95% CI 1.0 to 1.0]; <i>p</i> < 0.001). Despite carbetocin costing 10 times more than oxytocin, mean total healthcare costs were similar, adjusted group difference 31 NOK ($3 USD; €3; [95% CI –361 to 298 NOK]; <i>p</i> = 0.85).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Ischaemic myocardial risk and healthcare costs were comparable for both drugs. Patients receiving carbetocin maintained better uterine tone and required fewer rescue treatments.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>EudraCT: 2014–000507-27; ClinicalTrials.gov Identifier: NCT03899961 (02/04/2019)</p>\n </section>\n </div>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 12","pages":"1742-1752"},"PeriodicalIF":4.3000,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effects of Prophylactic Oxytocin or Carbetocin on Troponin Release and Postpartum Haemorrhage at Planned Caesarean Delivery: A Double-Blind Randomised Controlled Trial\",\"authors\":\"Maria E. Bekkenes, Marte M. Jørgensen, Anne F. Jacobsen, Morten W. 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Secondary endpoints included blood loss, uterine tone (numerical rating scale 0–10), rescue treatment, and healthcare costs 48 h postpartum.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>215 patients underwent a planned caesarean delivery and received their allocated study drug (oxytocin group, <i>n</i> = 112; carbetocin group, <i>n</i> = 103). We detected no difference in median change from baseline cTnI concentration at 6–10 h postpartum (0.0 [95% CI –1.09 to 1.09] ng/L; <i>p</i> = 1.00). Median (interquartile range [IQR]) estimated blood loss was similar: oxytocin, 395 (96 to 627) mL; carbetocin, 335 (127 to 570) mL (group difference: −41 mL [95% CI –158 to 76]; <i>p</i> = 0.49). Rescue treatment utilisation was higher with oxytocin (46.4%) versus carbetocin (27.2%); risk difference. (−19.2% [95% CI –31.2 to −6.3]; <i>p</i> = 0.004). 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引用次数: 0
摘要
目的催产素可能引起剂量依赖性心肌副作用。我们调查了长效催产素类似物卡比催产素是否会引起类似的变化。设计：双盲随机试验。大学医院，奥斯陆，挪威。人口：计划剖腹产的单胎孕妇240例，年龄18-50岁。方法1∶1随机分组，分娩后立即静脉注射催产素2.5 IU或卡贝霉素100 μg。主要结局指标：主要终点是产后6-10小时心肌肌钙蛋白I （cTnI）血清浓度较基线的变化。次要终点包括出血量、子宫张力（数值评分0-10）、抢救治疗和产后48小时的医疗费用。结果215例患者接受了计划剖宫产，并接受了分配的研究药物(催产素组，n = 112；卡贝菌素组，n = 103)。我们检测到产后6-10小时cTnI浓度与基线相比的中位数变化无差异(0.0 [95% CI -1.09至1.09]ng/L；p = 1.00)。中位数（四分位数间距[IQR]）估计失血量相似：催产素，395(96至627)mL；卡贝菌素，335 (127 ~ 570)mL(组差：-41 mL [95% CI: -158 ~ 76]；p = 0.49)。催产素（46.4%）比催产素（27.2%）在抢救治疗中的使用率更高；风险不同。(-19.2% [95% CI -31.2至-6.3]；p = 0.004)。分娩后5分钟，催产素组子宫张力中位数（IQR）较催产素组低（7[6 ~ 8]），催产素组较催产素组低（8 [7 ~ 9]）；组间差异1.0 NRS [95% CI 1.0 ~ 1.0]；p < 0.001)。尽管催产素的成本是催产素的10倍，但平均总医疗成本相似，调整后的组差异为31挪威克朗(3美元；€3;[95% CI -361 ~ 298 NOK]；p = 0.85)。结论两种药物的心肌缺血风险和医疗费用具有可比性。接受卡贝菌素治疗的患者维持子宫张力较好，需要的抢救治疗较少。试验注册号：2014-000507-27；ClinicalTrials.gov标识符：NCT03899961（02/04/2019）。
Effects of Prophylactic Oxytocin or Carbetocin on Troponin Release and Postpartum Haemorrhage at Planned Caesarean Delivery: A Double-Blind Randomised Controlled Trial
Objective
Oxytocin may cause dose-dependent myocardial side effects. We investigated if carbetocin, a long-acting oxytocin analogue, causes similar changes.
Design
Double-blind randomised trial.
Setting
University Hospitals, Oslo, Norway.
Population
240 singleton pregnant women, 18–50 years, undergoing planned caesarean delivery.
Methods
Participants, randomised 1:1, received oxytocin 2.5 IU or carbetocin 100 μg intravenously immediately after delivery.
Main Outcome Measures
The primary endpoint was change from baseline in cardiac troponin I (cTnI) serum concentration at 6–10 h postpartum. Secondary endpoints included blood loss, uterine tone (numerical rating scale 0–10), rescue treatment, and healthcare costs 48 h postpartum.
Results
215 patients underwent a planned caesarean delivery and received their allocated study drug (oxytocin group, n = 112; carbetocin group, n = 103). We detected no difference in median change from baseline cTnI concentration at 6–10 h postpartum (0.0 [95% CI –1.09 to 1.09] ng/L; p = 1.00). Median (interquartile range [IQR]) estimated blood loss was similar: oxytocin, 395 (96 to 627) mL; carbetocin, 335 (127 to 570) mL (group difference: −41 mL [95% CI –158 to 76]; p = 0.49). Rescue treatment utilisation was higher with oxytocin (46.4%) versus carbetocin (27.2%); risk difference. (−19.2% [95% CI –31.2 to −6.3]; p = 0.004). Median (IQR) uterine tone at 5 min after delivery was lower with oxytocin (7 [6 to 8]) versus carbetocin (8 [7 to 9]; group difference 1.0 NRS [95% CI 1.0 to 1.0]; p < 0.001). Despite carbetocin costing 10 times more than oxytocin, mean total healthcare costs were similar, adjusted group difference 31 NOK ($3 USD; €3; [95% CI –361 to 298 NOK]; p = 0.85).
Conclusions
Ischaemic myocardial risk and healthcare costs were comparable for both drugs. Patients receiving carbetocin maintained better uterine tone and required fewer rescue treatments.
期刊介绍：
BJOG is an editorially independent publication owned by the Royal College of Obstetricians and Gynaecologists (RCOG). The Journal publishes original, peer-reviewed work in all areas of obstetrics and gynaecology, including contraception, urogynaecology, fertility, oncology and clinical practice. Its aim is to publish the highest quality medical research in women''s health, worldwide.
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