Assessing the clinical use of a novel, mobile fetal monitoring device.

INTRODUCTION: The Sense4Baby system is a novel, wireless, noninvasive maternal and fetal monitor that locally transmits cardiotocography data and uploads it for a clinician. This device can help address health care disparities in high-risk pregnant women in underserved and remote areas by capturing and relaying data in a more cost-effective manner. The clinical use of the recording and interpretation capability of the Sense4Baby system device was compared with a U.S. Food and Drug Administration-approved predicate cardiotocograph (Philips system).

METHODS: Under the direction of board-certified obstetricians, sequential testing of the two cardiotocography units was carried out on 20 women in a prenatal clinic in the United States. Three board-certified obstetricians assessed the performance of both the Sense4Baby system and predicate devices by rating the clinical use and usability of the cardiotocography data output by each device.

RESULTS: Adequate recordings obtained by both systems for all 20 women. Comparing the Sense4Baby system and Phillips systems, there was no significant difference in the ability of the Sense4Baby system device to capture 1) baseline fetal heart rate; 2) accelerations; 3) decelerations; and 4) contractions. Furthermore, compared with the predicate tracings, the Sense4Baby system tracings were able to provide enough information so that each obstetrician was able to provide a meaningful clinical diagnosis.

CONCLUSIONS: These results demonstrate the clinical use of the Sense4Baby system regarding cardiotocography monitoring with signal quality comparable to that of standard fetal monitors. The use of telemedicine devices may offer cost-effective solutions for maternity health care in underserved areas, in the home, underdeveloped countries, or emergency departments.