PDF(Pubmed)
Abstract：
BACKGROUND: Our objective was to assess non-inferiority of the unique approach used in our institution of combined 10 IU IM (intramyometrial) and 10 IU IV (intravenous) oxytocin to carbetocin IV in preventing severe postpartum blood loss in elective cesarean sections. The design was a prospective controlled phase IV non-inferiority interventional trial. The setting was a tertiary center at University Hospital, Zurich, Switzerland.
METHODS: The population consisted of 550 women undergoing elective cesarean section after 36 completed weeks of gestation at low risk for postpartum hemorrhage (PPH). Participants were assigned to either combined oxytocin regimen (10 IU IM and 10 IU IV) or carbetocin (100 μg IV). Non-inferiority for oxytocin for severe PPH was assessed with a 0.05 margin using the Newcombe-Wilson score method. The main outcome measures were severe postpartum blood loss defined as delta hemoglobin (∆Hb, Hb prepartum-Hb postpartum) ≥30 g/L.
RESULTS: Non-inferiority of combined oxytocin (IM/IV) in preventing severe postpartum blood loss was not shown (17 women in the oxytocin group vs. 7 in the carbetocin group). The number needed to treat when using carbetocin was 28. The risk difference for ∆Hb ≥30 g/L was 0.04 (oxytocin 0.06 vs. 0.03), 95% confidence interval (CI) (0.00-0.08). No significant difference was observed for ∆Hb (median 12 [IQR 7.0-19.0] vs. 11 [5.0-17.0], p = 0.07), estimated blood loss (median 500 [IQR 400-600] vs. 500 [400-575], p = 0.38), or the PPH rate defined as estimated blood loss ≥1000 mL (12[4.5] vs. 5 [2.0], risk difference 0.03, 95% CI (-0.01 to 0.06), p = 0.16). More additional uterotonics were administered in the oxytocin group compared to the carbetocin group (15.2% vs. 5.9%, p = 0.001). Total case costs were non-significantly different in the oxytocin group (US $ 10 146 vs. 9621, mean difference 471.4, CI (-476.5 to 1419.3), p = 0.33).
CONCLUSIONS: Combined (IM/IV) oxytocin is not non-inferior to carbetocin regarding severe postpartum blood loss defined as postpartum Hb decrease ≥30 g/L in elective cesarean sections. We recommend carbetocin for use in clinical practice for elective cesarean sections.
METHODS: The population consisted of 550 women undergoing elective cesarean section after 36 completed weeks of gestation at low risk for postpartum hemorrhage (PPH). Participants were assigned to either combined oxytocin regimen (10 IU IM and 10 IU IV) or carbetocin (100 μg IV). Non-inferiority for oxytocin for severe PPH was assessed with a 0.05 margin using the Newcombe-Wilson score method. The main outcome measures were severe postpartum blood loss defined as delta hemoglobin (∆Hb, Hb prepartum-Hb postpartum) ≥30 g/L.
RESULTS: Non-inferiority of combined oxytocin (IM/IV) in preventing severe postpartum blood loss was not shown (17 women in the oxytocin group vs. 7 in the carbetocin group). The number needed to treat when using carbetocin was 28. The risk difference for ∆Hb ≥30 g/L was 0.04 (oxytocin 0.06 vs. 0.03), 95% confidence interval (CI) (0.00-0.08). No significant difference was observed for ∆Hb (median 12 [IQR 7.0-19.0] vs. 11 [5.0-17.0], p = 0.07), estimated blood loss (median 500 [IQR 400-600] vs. 500 [400-575], p = 0.38), or the PPH rate defined as estimated blood loss ≥1000 mL (12[4.5] vs. 5 [2.0], risk difference 0.03, 95% CI (-0.01 to 0.06), p = 0.16). More additional uterotonics were administered in the oxytocin group compared to the carbetocin group (15.2% vs. 5.9%, p = 0.001). Total case costs were non-significantly different in the oxytocin group (US $ 10 146 vs. 9621, mean difference 471.4, CI (-476.5 to 1419.3), p = 0.33).
CONCLUSIONS: Combined (IM/IV) oxytocin is not non-inferior to carbetocin regarding severe postpartum blood loss defined as postpartum Hb decrease ≥30 g/L in elective cesarean sections. We recommend carbetocin for use in clinical practice for elective cesarean sections.
摘要：
背景：我们的目的是评估在我们的机构中使用的10IUIM（肌层内）和10IUIV（静脉内）催产素与卡贝缩宫素IV联合预防选择性剖宫产产后严重失血的独特方法的非劣效性。该设计是一项前瞻性对照IV期非劣效性介入试验。设置是大学医院的三级中心，苏黎世,瑞士。
方法：该人群由550名妇女组成，她们在妊娠36周后接受选择性剖宫产，产后出血(PPH)风险较低。受试者被分配到联合催产素方案（10IUIM和10IUIV）或卡贝缩宫素（100μgIV）。使用Newcombe-Wilson评分法评估重度PPH的催产素的非劣效性为0.05。主要结局指标是严重的产后失血，定义为δ血红蛋白(ΔHb，产前Hb-产后Hb)≥30g/L
结果：未显示联合催产素（IM/IV）预防严重产后失血的非劣效性（催产素组17名妇女与卡贝缩宫素组中的7）。使用卡贝缩宫素时需要治疗的人数为28。ΔHb≥30g/L的风险差异为0.04(催产素0.06与0.03),95%置信区间(CI)(0.00-0.08)。ΔHb没有观察到显著差异（中位数12[IQR7.0-19.0]与11[5.0–17.0],p=0.07),估计失血量(中位数500[IQR400-600]vs.500[400-575],p=0.38)，或PPH率定义为估计失血≥1000mL（12[4.5]vs.5[2.0],风险差异0.03，95%CI(-0.01至0.06)，p=0.16）。与卡贝缩宫素组相比，催产素组给予更多额外的子宫收缩剂(15.2%vs.5.9%，p=0.001)。催产素组的总病例费用没有显着差异(US$10146vs.9621，平均差471.4，CI(-476.5至1419.3)，p=0.33）。
结论：联合（IM/IV）催产素在选择性剖宫产中严重产后失血（定义为产后Hb下降≥30g/L）方面并不劣于卡贝缩宫素。我们建议将卡贝缩宫素用于选择性剖宫产的临床实践。
方法：该人群由550名妇女组成，她们在妊娠36周后接受选择性剖宫产，产后出血(PPH)风险较低。受试者被分配到联合催产素方案（10IUIM和10IUIV）或卡贝缩宫素（100μgIV）。使用Newcombe-Wilson评分法评估重度PPH的催产素的非劣效性为0.05。主要结局指标是严重的产后失血，定义为δ血红蛋白(ΔHb，产前Hb-产后Hb)≥30g/L
结果：未显示联合催产素（IM/IV）预防严重产后失血的非劣效性（催产素组17名妇女与卡贝缩宫素组中的7）。使用卡贝缩宫素时需要治疗的人数为28。ΔHb≥30g/L的风险差异为0.04(催产素0.06与0.03),95%置信区间(CI)(0.00-0.08)。ΔHb没有观察到显著差异（中位数12[IQR7.0-19.0]与11[5.0–17.0],p=0.07),估计失血量(中位数500[IQR400-600]vs.500[400-575],p=0.38)，或PPH率定义为估计失血≥1000mL（12[4.5]vs.5[2.0],风险差异0.03，95%CI(-0.01至0.06)，p=0.16）。与卡贝缩宫素组相比，催产素组给予更多额外的子宫收缩剂(15.2%vs.5.9%，p=0.001)。催产素组的总病例费用没有显着差异(US$10146vs.9621，平均差471.4，CI(-476.5至1419.3)，p=0.33）。
结论：联合（IM/IV）催产素在选择性剖宫产中严重产后失血（定义为产后Hb下降≥30g/L）方面并不劣于卡贝缩宫素。我们建议将卡贝缩宫素用于选择性剖宫产的临床实践。
