预防性使用子宫收缩剂预防产程停滞剖宫产产妇产后出血的随机对照试验。

Prophylactic Administration of Uterotonics to Prevent Postpartum Hemorrhage in Women Undergoing Cesarean Delivery for Arrest of Labor: A Randomized Controlled Trial.

机构信息

Departments of Anesthesia and Pain Management and Obstetrics and Gynaecology, Mount Sinai Hospital, and the Lunenfeld-Tanenbaum Research Institute, Sinai Health System, Toronto, Ontario, the Department of Anesthesiology, Perioperative and Pain Medicine, University of Calgary, Calgary, Alberta, and the Institute of Health Policy, Management & Evaluation, University of Toronto, Toronto, Ontario, Canada.

出版信息

Obstet Gynecol. 2021 Mar 1;137(3):505-513. doi: 10.1097/AOG.0000000000004288.

DOI:10.1097/AOG.0000000000004288

PMID:33543897

Abstract

OBJECTIVE

To evaluate whether prophylactic administration of oxytocin plus ergonovine or oxytocin plus carboprost is more effective than oxytocin alone in reducing the need for additional uterotonics among women undergoing cesarean delivery for labor arrest.

METHODS

In this double-blind, three-arm randomized controlled trial, participants were assigned to receive either oxytocin 5 units intravenous alone, or with ergonovine 0.25 mg intravenous or carboprost 0.25 mg intramuscular immediately after delivery, followed with maintenance infusion of oxytocin 40 milliunits/minute in all groups. Uterine tone was assessed at 3, 5, and 10 minutes after delivery, and additional uterotonics were administered if deemed necessary. The primary outcome was intraoperative need for additional uterotonics. Secondary outcomes included uterine tone, calculated blood loss, and side effects. A sample size of 34 per group (n=102), based on the null hypothesis that there is no association between treatment assignment and the need for additional uterotonics, permitted independent post hoc pairwise comparisons between oxytocin plus ergonovine, oxytocin plus carboprost, and oxytocin alone using an adjusted P-value of .025. The association between the need for additional uterotonics and treatment group was assessed using the χ2 test.

RESULTS

From June 2013 through July 2019, 105 participants were randomized (35 per group) and data from 100 participants were analyzed: oxytocin (n=35), oxytocin plus ergonovine (n=33), and oxytocin plus carboprost (n=32). There was no difference in the requirement of additional intraoperative uterotonics across groups (oxytocin [37%] vs oxytocin plus ergonovine [33%] vs oxytocin plus carboprost [34%], P=.932). Uterine tone and calculated blood loss were similar across groups. Incidence of nausea or vomiting was higher in oxytocin plus ergonovine (85%; odds ratio [OR] 5.3, 95% CI 1.7-16.9, P=.003) and oxytocin plus carboprost (72%; OR 2.4, 95% CI 0.9-6.7, P=.086) compared with the oxytocin (51%) group.

CONCLUSION

Compared with oxytocin alone, prophylactic use of a combination of uterotonic drugs did not reduce the need for additional uterotonics at cesarean delivery for labor arrest.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, NCT01869556.

摘要

目的

评估缩宫素联合麦角新碱或缩宫素联合卡前列素用于预防剖宫产术中宫缩乏力时，与单独使用缩宫素相比，是否能更有效地减少对额外宫缩剂的需求。

方法

这是一项双盲、三臂随机对照试验，参与者被分配接受以下治疗：单独静脉注射缩宫素 5 单位，或在分娩后立即静脉注射麦角新碱 0.25mg 或卡前列素 0.25mg，然后在所有组中以 40 毫单位/分钟的速度维持输注缩宫素。在分娩后 3、5 和 10 分钟评估子宫张力，如果需要，给予额外的宫缩剂。主要结局是术中需要额外的宫缩剂。次要结局包括子宫张力、计算出血量和副作用。根据假设治疗分配与额外宫缩剂的需求之间没有关联，基于 34 名参与者/组（n=102）的样本量，允许使用调整后的 P 值为 0.025 进行缩宫素联合麦角新碱、缩宫素联合卡前列素与缩宫素单独治疗之间的事后两两比较。使用 χ2 检验评估额外宫缩剂需求与治疗组之间的关系。

结果

2013 年 6 月至 2019 年 7 月，105 名参与者被随机分配（每组 35 名），100 名参与者的数据被分析：缩宫素（n=35）、缩宫素联合麦角新碱（n=33）和缩宫素联合卡前列素（n=32）。三组之间术中额外使用宫缩剂的需求没有差异（缩宫素[37%]与缩宫素联合麦角新碱[33%]与缩宫素联合卡前列素[34%]，P=.932）。各组子宫张力和计算出血量相似。恶心或呕吐的发生率在缩宫素联合麦角新碱（85%；优势比[OR]5.3，95%CI 1.7-16.9，P=.003）和缩宫素联合卡前列素（72%；OR 2.4，95%CI 0.9-6.7，P=.086）组高于缩宫素（51%）组。