STAN as an adjunct to intrapartum fetal heart rate monitoring did not improve perinatal outcomes
In a study to be presented on Feb. 5 in an oral plenary session at 8 a.m. PST, at the Society for Maternal-Fetal Medicine's annual meeting, The Pregnancy Meeting, in San Diego, researchers will report that use of the ST segment (STAN) as an adjunct to conventional intrapartum electronic fetal heart rate monitoring did not improve perinatal outcomes or decrease operative deliveries in hospitals in the United States. STAN is used in Europe as an adjunct to conventional intrapartum fetal heart rate monitoring, and was approved by the FDA for use in the US, mostly based on results of studies in Europe and one small study in the US.
The study, titled Fetal ECG Analysis of the ST Segment as an Adjunct to Intrapartum Fetal Heart Rate Monitoring; A Randomized Clinical Trial, sought to determine whether monitoring the fetal electrocardiogram in addition to the usual monitoring during labor improves perinatal outcomes and decreases operative deliveries in 26 hospitals within the U.S. Researchers at centers affiliated with the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network enrolled 11,108 women in labor who were randomized to monitoring with STAN plus usual monitoring versus usual monitoring only. Unlike what was found in Europe, addition of STAN to the usual monitoring did not improve outcomes of the baby nor did it decrease cesarean deliveries in this study, the largest one to date..
The study highlights the need for caution when extrapolating results from studies outside the U.S. and the importance of testing medical interventions and technologies in the settings and populations where they will be applied. Introduction of medical interventions and technologies without appropriate testing can result in increased cost and potentially worsening of outcomes.
"Fortunately, the rates of adverse neonatal outcomes were overall low, stated George Saade, M.D., one of the researchers on the study who will be presenting the findings at the SMFM annual meeting." With the high rates of cesarean deliveries in the US, largely due to unreliable methods of monitoring during labor, it is essential that we continue research to find better ways to assess the well being of the baby."
The study is the largest randomized trial of its kind in the US, and would not have been possible without the support of the Kennedy Shriver National Institute of Child Health and Human Development. The need for this large number of patients, multiple sites, and several years are reminders of the challenges faced by researchers striving to improve neonatal outcomes and decrease cesarean deliveries. The quest for better methods to monitor women in labor and for better approaches to decreasing cesarean rates remains on. It is imperative that we increase funding in this area of research.
