产妇脉压与继发性硬膜外并发症的风险:随机对照试验

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 Maternal Pulse Pressure and the Risk of Postepidural Complications: A Randomized Controlled Trial

背景与目的

验证在硬膜外窄脉压患者硬膜外置管时增加静脉输液量,可减少硬膜后胎心率(Fhr)异常、低血压和产科复苏干预的假设

方  法

我们进行了单中心随机对照试验。符合条件的参与者是正常血压,35周或35周后有非异常的单胎妊娠,入院时脉搏压力窄(小于45毫米Hg)。如果入院后6小时内,患者仍有资格接受硬膜外随机化治疗,而FHR仍为1类。在硬膜外置管时,病人被分配到500毫升(机构标准)或1500毫升静脉药丸式推注。并对脉压≥50 mm的对照组进行评价。主要结果是硬膜外试验剂量后60分钟内出现2或3 FHR类型。评估的次要结果包括产妇低血压和纠正FHR异常或低血压的复合复苏干预。我们计算出276个女性(138个/组)将提供80%的能力以检测出初级结局的发生相对减少50%,从500毫升组的27%下降到1500毫升组的13.5%(双侧α=0.05)。

结  果

2015年10月至2016年11月,276个妇女接受了500 ml(n=139)或1500 ml(n=137)的输液,一百三十八名妇女在参照组中进行了评估。人口统计、产科和分娩特征相似,1500~ml组的继发性硬膜后胎心率(Fhr)异常明显减少(38.0%与51.8%相比,相对危险度0.73,95%Ci 0.56~0.96,p=.02)。1500~ml组产妇收缩压下降(10.2%比34.5%,相对危险度0.30,95%ci 0.17~0.51,p<0.001)和复合硬膜外介入治疗(18.3%例,44.2%例,相对危险度0.42,95%ci 0.42-0.42,p<0.001)发生率较低。胎儿心率异常在对照组中仍然明显低于入院分娩时脉搏压力较窄的妇女。

结  论

在脉搏压力较窄的妇女中使用1500毫升静脉药丸输注可降低出现硬膜后胎心率(Fhr)异常的风险(治疗次数=7),较少发生继发性硬膜后低血压,减少了复苏干预的需要。在椎管内分娩镇痛的起始时间,入院脉压可用于个性化分娩期液体管理。

原始文献摘要

Lappen JR1, Myers SA, Bolen N,   et al. Maternal Pulse Pressure and the Risk of Postepidural Complications: A Randomized Controlled Trial. Obstet Gynecol. 2017 Dec;130(6):1366-1376. doi: 10.1097/AOG.0000000000002326.

Abstract

OBJECTIVE:

To test the hypothesis that increasing the intravenous fluid bolus volume at the time of epidural placement in women with narrow pulse pressure would reduce postepidural fetal heart rate (FHR) abnormalities, hypotension, and resuscitative obstetric interventions.

METHODS:

We performed a single-center randomized controlled trial. Eligible participants were normotensive with a nonanomalous singleton gestation at or after 35 weeks and with a narrow pulse pressure (less than 45 mm Hg) on admission. Enrolled patients remained eligible for randomization at epidural request if they were within 6 hours of admission and the FHR remained category 1. Patients were allocated to a 500-mL (institutional standard) or 1,500-mL intravenous fluid bolus at epidural placement. A reference group with admission pulse pressure 50 mm Hg or greater was also evaluated. The primary outcome was a category 2 or 3 FHR pattern within 60 minutes after the epidural test dose. Evaluated secondary outcomes included maternal hypotension and composite resuscitative interventions to correct FHR abnormalities or hypotension. We calculated that 276 women (138/group) would provide 80% power to detect a relative 50% reduction in the occurrence of the primary outcome from 27% in the 500-mL group to 13.5% in the 1,500-mL group (two-sided α=0.05).

RESULTS:

From October 2015 to November 2016, 276 women were allocated to receive a 500-mL (n=139) or 1,500-mL (n=137) fluid bolus. One hundred thirty-eight women were evaluated in the reference group. Demographic, obstetric, and labor characteristics were similar between groups. The 1,500-mL group had significantly fewer postepidural FHR abnormalities (38.0% compared with 51.8%, relative risk 0.73, 95% CI 0.56-0.96, P=.02). Maternal systolic hypotension (10.2% compared with 34.5%, relative risk 0.30, 95% CI 0.17-0.51, P<.001) and composite postepidural interventions (18.3% compared with 44.2%, relative risk 0.42, 95% CI 0.28-0.62, P<.001) were also less frequent in the 1,500-mL group. Fetal heart rate abnormalities remained significantly less frequent in the reference group than among women with a narrow pulse pressure on admission for delivery.

CONCLUSION:

A 1,500-mL intravenous fluid bolus in women with a narrow pulse pressure decreases the risk of postepidural FHR abnormalities (number needed to treat=7), results in less frequent postepidural hypotension, and reduces the need for resuscitative interventions. Admission pulse pressure may be used to individualize intrapartum fluid management at the time of initiation of neuraxial labor analgesia.

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