马来酸麦角新碱预防剖宫产术产妇产后出血的多中心随机双盲对照临床研究

A multicenter,double-blind,randomized controlled clinical trial comparing ergometrine with oxytocin and oxytocin alone for prevention of postpartum hemorrhage at cesarean section

目的评价马来酸麦角新碱用于预防剖宫产术产妇产后出血的有效性和安全性。方法本研究采用多中心、随机、双盲、对照的临床研究设计,于2018年12月至2019年11月在全国16家医院开展,共纳入298例产妇,按1∶1比例随机分配分为试验组(马来酸麦角新碱注射液+缩宫素注射液)148例,对照组(缩宫素注射液)150例。比较两组产妇下列指标的差异:(1)主要指标:产后2 h总出血量;(2)次要指标:产后6、24 h出血量,胎盘滞留时间,产后出血的发生率,产后2、24 h额外使用促宫缩药物、止血药物或其他止血措施的比例,需要输血比例,因子宫复旧不良导致住院时间延长的比例;(3)安全性指标:恶心、呕吐、头晕等副反应,各给药时间点的血压。结果(1)试验组产妇产后2 h总出血量[(402±18)ml]少于对照组[(505±18)ml],两组比较,差异有统计学意义(P<0.05)。(2)试验组产后6、24 h出血量少于对照组,分别比较,差异均有统计学意义(P均<0.05)。两组产后出血的发生率,产后2、24 h额外使用促宫缩药物、止血药物或其他止血措施的比例,需要输血比例,因子宫复旧不良导致住院时间延长的比例分别比较,差异均无统计学意义(P均>0.05)。(3)试验组2例(1.4%,2/148)产妇出现副反应,对照组有1例(0.7%,1/150)出现副反应,两组比较,差异无统计学意义(P>0.05)。试验组产妇给药2.0 h及以内的收缩压高于对照组,给药1.5 h及以内的舒张压高于对照组,分别比较,差异均有统计学意义(P均<0.05);但两组血压均在正常范围。结论剖宫产术中使用马来酸麦角新碱注射液可减少产后出血量,安全可行。

Objective 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).Methods 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.Results(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(P<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 P<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 P>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(P>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(P<0.05),but the blood pressure of the two groups were in the normal range.Conclusion The use of ergometrine injection in CS could reduce the amount of PPH,which is safe and feasible.