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经阴道与经腹壁宫缩压力监测用于产程监测的结局比较。

Outcomes after internal versus external tocodynamometry for monitoring labor.

机构信息

Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, The Netherlands.

出版信息

N Engl J Med. 2010 Jan 28;362(4):306-13. doi: 10.1056/NEJMoa0902748.

Abstract

BACKGROUND

It has been hypothesized that internal tocodynamometry, as compared with external monitoring, may provide a more accurate assessment of contractions and thus improve the ability to adjust the dose of oxytocin effectively, resulting in fewer operative deliveries and less fetal distress. However, few data are available to test this hypothesis.

METHODS

We performed a randomized, controlled trial in six hospitals in The Netherlands to compare internal tocodynamometry with external monitoring of uterine activity in women for whom induced or augmented labor was required. The primary outcome was the rate of operative deliveries, including both cesarean sections and instrumented vaginal deliveries. Secondary outcomes included the use of antibiotics during labor, time from randomization to delivery, and adverse neonatal outcomes (defined as any of the following: an Apgar score at 5 minutes of less than 7, umbilical-artery pH of less than 7.05, and neonatal hospital stay of longer than 48 hours).

RESULTS

We randomly assigned 1456 women to either internal tocodynamometry (734) or external monitoring (722). The operative-delivery rate was 31.3% in the internal-tocodynamometry group and 29.6% in the external-monitoring group (relative risk with internal monitoring, 1.1; 95% confidence interval [CI], 0.91 to 1.2). Secondary outcomes did not differ significantly between the two groups. The rate of adverse neonatal outcomes was 14.3% with internal monitoring and 15.0% with external monitoring (relative risk, 0.95; 95% CI, 0.74 to 1.2). No serious adverse events associated with use of the intrauterine pressure catheter were reported.

CONCLUSIONS

Internal tocodynamometry during induced or augmented labor, as compared with external monitoring, did not significantly reduce the rate of operative deliveries or of adverse neonatal outcomes. (Current Controlled Trials number, ISRCTN13667534; Netherlands Trial number, NTR285.)

摘要

背景

据推测,与外部监测相比,内部宫缩压力监测可能对宫缩进行更准确的评估,从而提高有效调整催产素剂量的能力,减少剖宫产和胎儿窘迫的发生。然而,目前还没有数据可以验证这一假设。

方法

我们在荷兰的 6 家医院进行了一项随机对照试验,比较了需要引产或催产的产妇使用内部宫缩压力监测与外部子宫活动监测的效果。主要结局是剖宫产和器械助产分娩的手术分娩率。次要结局包括产程中抗生素的使用、随机分组到分娩的时间以及不良新生儿结局(定义为以下任何一项:5 分钟时 Apgar 评分<7 分、脐动脉 pH 值<7.05、新生儿住院时间>48 小时)。

结果

我们将 1456 名妇女随机分配到内部宫缩压力监测组(734 名)或外部监测组(722 名)。内部宫缩压力监测组的手术分娩率为 31.3%,外部监测组为 29.6%(内部监测的相对风险为 1.1;95%置信区间[CI]为 0.91 至 1.2)。两组次要结局无显著差异。内部监测组新生儿不良结局发生率为 14.3%,外部监测组为 15.0%(相对风险为 0.95;95%CI 为 0.74 至 1.2)。未报告与使用宫腔压力导管相关的严重不良事件。

结论

与外部监测相比,在引产或催产期间使用内部宫缩压力监测并不能显著降低手术分娩率或新生儿不良结局的发生率。(当前对照试验编号:ISRCTN87104164;荷兰试验编号:NTR285。)

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