预防性麦角新碱和缩宫素与单独使用缩宫素在产时剖宫产患者中的比较：一项随机对照试验。
Prophylactic Methylergonovine and Oxytocin Compared With Oxytocin Alone in Patients Undergoing Intrapartum Cesarean Birth: A Randomized Controlled Trial.
机构信息
Department of Maternal Fetal Medicine and the Department of Anesthesia, University of Iowa Hospitals and Clinics, Iowa City, Iowa.
出版信息
Obstet Gynecol. 2022 Aug 1;140(2):181-186. doi: 10.1097/AOG.0000000000004857. Epub 2022 Jul 6.
OBJECTIVE
To evaluate whether the administration of prophylactic methylergonovine in addition to oxytocin in patients undergoing intrapartum cesarean birth reduces the need for additional uterotonic agents.
METHODS
This was a single-center, placebo-controlled, randomized trial of patients undergoing intrapartum cesarean birth. Patients were randomly allocated to receive intravenous oxytocin 300 mL/minute plus intramuscular methylergonovine 0.2 mg (1 mL) or intravenous oxytocin 300 mL/minute plus intramuscular normal saline (1 mL). The primary outcome was the receipt of additional uterotonic agents. Secondary outcomes included surgeon assessment of uterine tone, incidence of postpartum hemorrhage, quantitative blood loss, and blood transfusion. To detect a twofold decrease in the need for additional uterotonic agents (assuming a 42% baseline) with a two-sided type 1 error of 5% and power of 80%, a sample size of 76 patients per group was required.
RESULTS
From June 2019 through February 2021, 80 patients were randomized to receive methylergonovine plus oxytocin and 80 were randomized to receive to oxytocin alone. Significantly fewer patients who were allocated to the methylergonovine group received additional uterotonic agents (20% vs 55%, relative risk [RR] 0.4, 95% CI 0.2-0.6). Participants receiving methylergonovine were more likely to have satisfactory uterine tone (80% vs 41%, RR 1.9, 95% CI 1.5-2.6), lower incidence of postpartum hemorrhage (35% vs 59%, RR 0.6, 95% CI 0.4-0.9), lower mean quantitative blood loss (967 mL vs 1,315 mL; mean difference 348, 95% CI 124-572), and a lower frequency of blood transfusion (5% vs 23%, RR 0.2, 95% CI 0.1-0.6).
CONCLUSION
The administration of prophylactic methylergonovine in addition to oxytocin in patients undergoing intrapartum cesarean birth reduces the need for additional uterotonic agents.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT03904446.
目的
评估在接受产时剖宫产的患者中，除催产素外给予预防性麦角新碱是否减少了对额外子宫收缩剂的需求。
方法
这是一项在接受产时剖宫产的患者中进行的单中心、安慰剂对照、随机试验。患者被随机分配接受静脉滴注催产素 300mL/分钟加肌肉注射麦角新碱 0.2mg（1mL）或静脉滴注催产素 300mL/分钟加肌肉注射生理盐水 1mL。主要结局是接受额外子宫收缩剂。次要结局包括外科医生评估子宫收缩情况、产后出血发生率、出血量和输血。为了检测到与基线相比，需要两倍减少额外子宫收缩剂的需求（假设基线为 42%），双侧 1 型错误为 5%，效能为 80%，每组需要 76 名患者的样本量。
结果
2019 年 6 月至 2021 年 2 月，80 名患者被随机分配接受麦角新碱加催产素，80 名患者被随机分配接受催产素单药治疗。接受麦角新碱组接受额外子宫收缩剂的患者明显减少（20% vs 55%，相对风险[RR]0.4，95%置信区间[CI]0.2-0.6）。接受麦角新碱的患者更有可能有满意的子宫收缩（80% vs 41%，RR 1.9，95% CI 1.5-2.6），产后出血发生率较低（35% vs 59%，RR 0.6，95% CI 0.4-0.9），平均出血量较低（967ml vs 1315ml；平均差值 348，95% CI 124-572），输血频率较低（5% vs 23%，RR 0.2，95% CI 0.1-0.6）。
结论
在接受产时剖宫产的患者中，除催产素外给予预防性麦角新碱可减少对额外子宫收缩剂的需求。
临床试验注册
ClinicalTrials.gov，NCT03904446。
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