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.

中文翻译：

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产时剖宫产患者预防性使用甲基麦角新碱和催产素与单独使用催产素的比较：一项随机对照试验

客观的： 

评估在进行产时剖宫产的患者中，除催产素外，预防性使用甲基麦角新碱是否会减少对额外宫缩剂的需求。

方法： 

这是一项针对产时剖宫产患者的单中心、安慰剂对照、随机试验。患者被随机分配接受静脉注射催产素 300 毫升/分钟加肌肉注射甲基麦角新碱 0.2 毫克（1 毫升）或静脉注射催产素 300 毫升/分钟加肌肉注射生理盐水（1 毫升）。主要结果是接受额外的宫缩剂。次要结局包括外科医生对子宫张力、产后出血发生率、定量失血和输血的评估。为了检测额外宫缩剂的需求减少了两倍（假设基线为 42%），两侧 1 型误差为 5%，功效为 80%，需要每组 76 名患者的样本量。

结果： 

从 2019 年 6 月到 2021 年 2 月，80 名患者被随机分配接受甲基麦角新碱加催产素治疗，80 名患者被随机分配接受催产素单独治疗。分配到甲基麦角新碱组的患者接受额外宫缩剂的患者明显减少（20% vs 55%，相对风险 [RR] 0.4，95% CI 0.2-0.6）。接受甲基麦角新碱的参与者更有可能获得令人满意的子宫张力（80% vs 41%，RR 1.9，95% CI 1.5-2.6），产后出血的发生率更低（35% vs 59%，RR 0.6，95% CI 0.4-0.9 )、较低的平均定量失血量（967 mL vs 1,315 mL；平均差 348, 95% CI 124–572）和较低的输血频率（5% vs 23%, RR 0.2, 95% CI 0.1–0.6） .

结论： 

在进行产时剖宫产的患者中，除催产素外，预防性使用甲基麦角新碱可减少对额外宫缩剂的需求。

临床试验注册： 

ClinicalTrials.gov，NCT03904446。