Scientific and clinical evidence for the use of fetal ECG ST segment analysis (STAN)

Steer, Philip; Hvidman, Lone

doi:10.1111/aogs.12369

Cited by 11 publications

(11 citation statements)

References 42 publications

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“…11 It has also been suggested that there is a learning curve with ST-segment analysis. A reanalysis of the meta-analysis by Schuit et al showed that labor management with the use of ST-segment analysis reduced metabolic acidosis and adverse neonatal outcomes in the second half of the trials.…”

Section: Discussionmentioning

confidence: 99%

“…However, the relevance of these results to usual obstetrical practice is unclear, given inconsistent findings among published trials and questions about eligibility criteria, choice and definition of primary outcomes, and intrapartum management, as discussed by Øian and Blix 10 and Steer and Hvidman. 11 Moreover, there are substantive differences between U.S. and European practices. We designed a large, multi-institutional, randomized trial to assess the effects of using fetal ECG ST-segment analysis on perinatal outcomes.…”

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confidence: 99%

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A Randomized Trial of Intrapartum Fetal ECG ST-Segment Analysis

Belfort

Saade

Thom

et al. 2015

Obstetrical &Amp; Gynecological Survey

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

A Randomized Trial of Intrapartum Fetal ECG ST-Segment Analysis

Belfort

Saade

Thom

et al. 2015

Obstetrical &Amp; Gynecological Survey

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confidence: 99%

A Randomized Trial of Intrapartum Fetal ECG ST-Segment Analysis

et al. 2015

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BACKGROUND It is unclear whether using fetal electrocardiographic (ECG) ST-segment analysis as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring modifies intrapartum and neonatal outcomes. METHODS We performed a multicenter trial in which women with a singleton fetus who were attempting vaginal delivery at more than 36 weeks of gestation and who had cervical dilation of 2 to 7 cm were randomly assigned to “open” or “masked” monitoring with fetal ST-segment analysis. The masked system functioned as a normal fetal heart-rate monitor. The open system displayed additional information for use when uncertain fetal heart-rate patterns were detected. The primary outcome was a composite of intrapartum fetal death, neonatal death, an Apgar score of 3 or less at 5 minutes, neonatal seizure, an umbilical-artery blood pH of 7.05 or less with a base deficit of 12 mmol per liter or more, intubation for ventilation at delivery, or neonatal encephalopathy. RESULTS A total of 11,108 patients underwent randomization; 5532 were assigned to the open group, and 5576 to the masked group. The primary outcome occurred in 52 fetuses or neonates of women in the open group (0.9%) and 40 fetuses or neonates of women in the masked group (0.7%) (relative risk, 1.31; 95% confidence interval, 0.87 to 1.98; P = 0.20). Among the individual components of the primary outcome, only the frequency of a 5-minute Apgar score of 3 or less differed significantly between neonates of women in the open group and those in the masked group (0.3% vs. 0.1%, P = 0.02). There were no significant between-group differences in the rate of cesarean delivery (16.9% and 16.2%, respectively; P = 0.30) or any operative delivery (22.8% and 22.0%, respectively; P = 0.31). Adverse events were rare and occurred with similar frequency in the two groups. CONCLUSIONS Fetal ECG ST-segment analysis used as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring did not improve perinatal outcomes or decrease operative-delivery rates. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Neoventa Medical; ClinicalTrials.gov number, NCT01131260.)

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“…53 Three cases of intrapartum metabolic acidosis were documented by the Dutch group 54 and a paper from St. George’s Hospital in London reported on 14 cases of neonatal encephalopathy in the first 1052 patients who were monitored using STAN and stated that in only 7 of these 14 had there been a significant ST event. 55 It was subsequently established that STAN monitoring was being started when the fetal heart rate tracing was already abnormal, a finding that reinforces the importance of only starting STAN monitoring after a reassuring pattern has been established (and maintained until the baseline ST analysis is completed).…”

Section: The Randomized Trials and Their Analysismentioning

confidence: 99%

What we have learned about intrapartum fetal monitoring trials in the MFMU Network

Bloom

Belfort

Saade

2016

Seminars in Perinatology

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The vast majority of pregnant women in the United States are subjected to electronic fetal heart monitoring during labor. There is limited evidence to support its benefit compared with intermittent auscultation. In addition, there is significant variability in interpretation and its false positive rate is high. The latter may have contributed to the rise in operative deliveries. In order to address the critical need for better approaches to intrapartum monitoring, the MFMU Network has completed 2 large multi-site randomized trials, one to evaluate fetal pulse oximetry and the other to evaluate fetal ECG ST segment analysis (STAN). Both of these technologies had been approved for clinical use in the U.S. based on prior smaller trials. These technologies were evaluated in laboring women near term and their primary outcomes were overall cesarean delivery for the oximetry trial and a composite adverse neonatal outcome for STAN. Both trials failed to show a benefit of the technology, neither in the rates of operative deliveries nor in the rates of adverse neonatal outcomes. The experience with these trials, summarized in this report, highlights the need for rigorous evidence before introduction of new technology into clinical practice and provide a blueprint for future such trials to address the need for better intrapartum monitoring approaches.

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Scientific and clinical evidence for the use of fetal ECG ST segment analysis (STAN)

Cited by 11 publications

References 42 publications

A Randomized Trial of Intrapartum Fetal ECG ST-Segment Analysis

A Randomized Trial of Intrapartum Fetal ECG ST-Segment Analysis

A Randomized Trial of Intrapartum Fetal ECG ST-Segment Analysis

What we have learned about intrapartum fetal monitoring trials in the MFMU Network

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