title: United States multicenter clinical usage study of the STAN 21 electronic fetal monitoring system.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  US clinicians used the STAN system appropriately in a manner similar to that of experienced STAN users.
authors.affiliation: Department of Obstetrics and Gynecology, Medical College of Georgia, Augusta, GA 30912, USA. ldevoe@mail.mcg.edu
authors.forename: Lawrence D
authors.initials: LD
authors.lastname: Devoe
authors.forename: Michael
authors.initials: M
authors.lastname: Ross
authors.forename: Clayton
authors.initials: C
authors.lastname: Wilde
authors.forename: Maureen
authors.initials: M
authors.lastname: Beal
authors.forename: Andrej
authors.initials: A
authors.lastname: Lysikewicz
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Maier
authors.forename: Victor
authors.initials: V
authors.lastname: Vines
authors.forename: Isis
authors.initials: I
authors.lastname: Amer-Wåhlin
authors.forename: Håkan
authors.initials: H
authors.lastname: Lilja
authors.forename: Håkan
authors.initials: H
authors.lastname: Norén
authors.forename: Dev
authors.initials: D
authors.lastname: Maulik
mesh_terms: D000138:Acidosis / Q000175:diagnosis; D004562:Electrocardiography; D005240:Feasibility Studies; D005315:Fetal Diseases / Q000175:diagnosis*; D005323:Fetal Monitoring / Q000295:instrumentation* / Q000706:statistics & numerical data; D006340:Heart Rate, Fetal; D006801:Humans; D011237:Predictive Value of Tests; D011446:Prospective Studies; D014481:United States