United States Multicenter Clinical Usage Study of the STAN 21 Electronic Fetal Monitoring System

Lawrence D Devoe, Michael Ross, Clayton Wilde, Maureen Beal, Andrej Lysikewicz, Jeffrey Maier, Victor Vines, Isis Amer-Wåhlin, Håkan Lilja, Håkan Norén, Dev Maulik

Research output: Contribution to journalArticle

32 Scopus citations

Abstract

Objective: The fetal electrocardiogram system for electronic fetal monitoring (EFM) (STAN S21, Neoventa Medical, Moelndal, Sweden) has led to improved perinatal outcomes in other countries. We aimed to assess the ability of United States (US) obstetricians to use this system appropriately for intrapartum care. Study design: A prospective nonrandomized trial was conducted in 6 sites. Enrollment required a singleton vertex fetus, >36 weeks' gestation, with indications for direct fetal monitoring during first stage of labor. Appropriate use was measured by negative predictive value (NPV) of nonintervention for fetuses with nonreassuring fetal heart rate (FHR) patterns, normal STAN readings, and normal neonatal outcomes with umbilical cord arterial pH >7.12; and percent agreement (PA) for intervention decisions with 3 STAN experts who conducted retrospective case reviews blinded to outcome. Results: Five hundred and thirty patients were enrolled. An NPV of 95.2% was achieved while PA between investigators and STAN experts was 84%, and 90%, for intervention and nonintervention, respectively. No fetus with metabolic acidosis requiring intervention was missed by US clinicians. Conclusion: US clinicians used the STAN system appropriately in a manner similar to that of experienced STAN users.

Original languageEnglish (US)
Pages (from-to)729-734
Number of pages6
JournalAmerican journal of obstetrics and gynecology
Volume195
Issue number3
DOIs
StatePublished - Sep 1 2006

Keywords

  • Fetal electrocardiogram
  • Intrapartum fetal monitoring

ASJC Scopus subject areas

  • Obstetrics and Gynecology

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    Devoe, L. D., Ross, M., Wilde, C., Beal, M., Lysikewicz, A., Maier, J., Vines, V., Amer-Wåhlin, I., Lilja, H., Norén, H., & Maulik, D. (2006). United States Multicenter Clinical Usage Study of the STAN 21 Electronic Fetal Monitoring System. American journal of obstetrics and gynecology, 195(3), 729-734. https://doi.org/10.1016/j.ajog.2006.06.002