Panel doesn't endorse fetal heart rate monitor. (Lack of U.S. Data Cited).

GAITHERSBURG, MD. -- A fetal heart rate monitor that provides an analysis of the fetal ECG during labor was not recommended for approval during a meeting of the Food and Drug Administration's Obstetrics-Gynecology Panel.

The FDA ob.gyn. devices panel voted 6 to 5 that the device should not be approved, largely because it had not been studied in the United States. It was not clear whether the positive results seen in a large Swedish trial would translate to this country where obstetric practice is so much different, panelists said.

The STAN S 21 fetal heart monitor continuously measures the fetal ECG and heart rate via a scalp electrode, automatically identifying and analyzing T wave and ST segment changes, which reflect myocardial ability to respond to hypoxia, according to the monitor's Swedish manufacturer, Neoventa Medical. The device also monitors external heart rate and uterine activity.

The proposed indication for the device is for use in a planned vaginal delivery of a term singleton fetus in a vertex presentation when there is a need "for close fetal surveillance during labor, or there are maternal disorders and/or uteroplacental dysfunction with potential adverse influence on fetal oxygen and nutritional supply, or there is a deviation from the normal course of labor including induction/ augmentation of labor."

Representatives from the company presented data from a large Swedish multi-center, randomized controlled study of 2,159 women in labor managed with the STAN monitor and conventional monitoring, compared with 2,079 women who were managed with conventional monitoring alone. The primary end point was metabolic acidosis, defined as an umbilical cord arterial pH below 7.05 and a base deficit above 12 mmol/L.

The rate ...