He G L, Pan T Y, Liu X X, He S Y, Zhang L, Feng W S, Zhang J, He J, Xin W, Zhou Y L, Cao X C, He L, Yan Y P, You H Y, Cui F, Fang X X, Liang Q H, Cai M, Chen T, Li L, Wu Lin
Department of Obstetrics and Gynecology, Key Laboratory of Birth Defects and Related Diseases of Women and Children of Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu 610041, China.
Department of Obstetrics, Women's Hospital, Zhejiang University School of Medicine, Hangzhou 310006, China.
Zhonghua Fu Chan Ke Za Zhi. 2022 Nov 25;57(11):836-842. doi: 10.3760/cma.j.cn112141-20220630-00427.
To compare oxytocin combined with ergometrine with oxytocin alone in terms of primary prophylaxis for postpartum hemorrhage (PPH) at the time of cesarean section (CS). This was a multicenter double-blind randomized controlled interventional study comparing ergometrine combined with oxytocin and oxytocin alone administered at CS. From December 2018 to November 2019, a total of 298 parturients were enrolled in 16 hospitals nationwide. They were randomly divided into experimental group (ergometrine intra-myometrial injection following oxytocin intravenously; 148 cases) and control group (oxytocin intra-myometrial injection following oxytocin intravenously; 150 cases) according to 1∶1 random allocation. The following indexes were compared between the two groups: (1) main index: blood loss 2 hours (h) after delivery; (2) secondary indicators: postpartum blood loss at 6 h and 24 h, placental retention time, incidence of PPH, the proportion of additional use of uterine contraction drugs, hemostatic drugs or other hemostatic measures at 2 h and 24 h after delivery, the proportion requiring blood transfusion, and the proportion of prolonged hospital stay due to poor uterine involution; (3) safety indicators: nausea, vomiting, dizziness and other adverse reactions, and blood pressure at each time point of administration. (1) The blood loss at 2 h after delivery in the experimental group [(402±18) ml] was less than that in the control group [(505±18) ml], and the difference was statistically significant (<0.05). (2) The blood loss at 6 h and 24 h after delivery in the experimental group were less than those in the control group, and the differences were statistically significant (all <0.05). There were no significant differences between the two groups in the incidence of PPH, the proportion of additional use of uterine contraction drugs, hemostatic drugs or other hemostatic measures at 2 h and 24 h after delivery, the proportion requiring blood transfusion, and the proportion of prolonged hospital stay due to poor uterine involution (all >0.05). (3) Adverse reactions occurred in 2 cases (1.4%, 2/148) in the experimental group and 1 case (0.7%, 1/150) in the control group. There was no significant difference between the two groups (>0.05). The systolic blood pressure within 2.0 h and diastolic blood pressure within 1.5 h of drug administration in the experimental group were higher than those in the control group, and the differences were statistically significant (<0.05), but the blood pressure of the two groups were in the normal range. The use of ergometrine injection in CS could reduce the amount of PPH, which is safe and feasible.
比较剖宫产时缩宫素联合麦角新碱与单纯缩宫素用于产后出血（PPH）一级预防的效果。这是一项多中心双盲随机对照干预研究，比较剖宫产时麦角新碱联合缩宫素与单纯缩宫素的应用。2018年12月至2019年11月，全国16家医院共纳入298例产妇。根据1∶1随机分配，将她们随机分为试验组（静脉注射缩宫素后行麦角新碱肌层内注射；148例）和对照组（静脉注射缩宫素后行缩宫素肌层内注射；150例）。比较两组以下指标：（1）主要指标：产后2小时（h）失血量；（2）次要指标：产后6小时和24小时失血量、胎盘滞留时间、PPH发生率、产后2小时和24小时额外使用宫缩剂、止血药或其他止血措施的比例、输血比例以及因子宫复旧不良导致住院时间延长的比例；（3）安全指标：恶心、呕吐、头晕等不良反应以及给药各时间点的血压。（1）试验组产后2小时失血量[（402±18）ml]少于对照组[（505±18）ml]，差异有统计学意义（<0.05）。（2）试验组产后6小时和24小时失血量少于对照组，差异有统计学意义（均<0.05）。两组在PPH发生率、产后2小时和24小时额外使用宫缩剂、止血药或其他止血措施的比例、输血比例以及因子宫复旧不良导致住院时间延长的比例方面差异均无统计学意义（均>0.05）。（3）试验组有2例（1.4%，2/148）发生不良反应，对照组有1例（0.7%，1/150）发生不良反应。两组差异无统计学意义（>0.05）。试验组给药后2.0小时内收缩压和1.5小时内舒张压高于对照组，差异有统计学意义（<0.05），但两组血压均在正常范围内。剖宫产时使用麦角新碱注射液可减少PPH量，安全可行。
