TY - JOUR
T1 - United States Multicenter Clinical Usage Study of the STAN 21 Electronic Fetal Monitoring System
AU - Devoe, Lawrence D.
AU - Ross, Michael
AU - Wilde, Clayton
AU - Beal, Maureen
AU - Lysikewicz, Andrej
AU - Maier, Jeffrey
AU - Vines, Victor
AU - Amer-Wåhlin, Isis
AU - Lilja, Håkan
AU - Norén, Håkan
AU - Maulik, Dev
N1 - Funding Information:
Funding for this study was provided by Neoventa Medical, Moelndal, Sweden.
PY - 2006/9
Y1 - 2006/9
N2 - 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.
AB - 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.
KW - Fetal electrocardiogram
KW - Intrapartum fetal monitoring
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U2 - 10.1016/j.ajog.2006.06.002
DO - 10.1016/j.ajog.2006.06.002
M3 - Article
C2 - 16949404
AN - SCOPUS:33748708908
SN - 0002-9378
VL - 195
SP - 729
EP - 734
JO - American journal of obstetrics and gynecology
JF - American journal of obstetrics and gynecology
IS - 3
ER -