United States multicenter clinical usage study of the STAN 21 electronic fetal monitoring system.
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.
Devoe
Lawrence D
LD
Department of Obstetrics and Gynecology, Medical College of Georgia, Augusta, GA 30912, USA. ldevoe@mail.mcg.edu
Ross
Michael
M
Wilde
Clayton
C
Beal
Maureen
M
Lysikewicz
Andrej
A
Maier
Jeffrey
J
Vines
Victor
V
Amer-Wåhlin
Isis
I
Lilja
Håkan
H
Norén
Håkan
H
Maulik
Dev
D
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