COMPARATIVE STUDY TO DETERMINE THE RELIABILITY AND ACCURACY OF THE FETAL LITE ELECTRONIC FETAL MONITOR WHEN COMPARED WITH CONVENTIONAL CARDIOTOCOGRAPHY

Intrapartum deaths is a major concern in India. A total of 300,000 such cases that reported annually are linked to gaps in fetal monitoring during labor. The current point-of-care technology for fetal monitoring in India is called the Cardiotocography (CTG). The technology is an ultrasound and pressure transducer based measurement device. Results given by commercially available CTG devices are highly debatable due to perceived ambiguity in the output and the high skill-dependent modes of operation and interpretation. Recent advances have shown that using non-invasive transabdominal fetal Electrocardiogram (fECG) and Electrohysterogram (EHG) during labor is a more effective method for calculating fetal heart rate (FHR) and uterine contractions (UC). A new device called the Fetal Lite has been developed by an Indian company called Sattva MedTech based on this technology. The aim of this study is to perform a systematic comparison between the Fetal Lite against a traditional CTG monitor to determine it's reliability and accuracy. The GE Corometrics 170 series CTG device is a state of the art, commercially available CTG device that was chosen as the reference for the measurement. FHR and UC data were collected from 12 patients using the Fetal Lite and the CTG simultaneously. Volunteers were made aware of the comparison study being performed and a consent form was signed by each volunteer. Comparable trace data of 201 minutes was collected from consenting mothers with singleton pregnancies, who were beyond 36 weeks of gestation and who were in labor. This data was sampled every 10s and outlier data was discarded as per FIGO guidelines. A total of 1053 Fetal heart-rate samples were obtained and statistical methods were used to determine the reliability and accuracy of the Fetal Lite v/s the Corometrics 170 monitor. The overall FHR PPA was estimated to be 93.87%. The 95% limits of agreement from the Bland-Altman plot is 11.85 bpm, -11.56 bpm with a bias of -0.08. The RMS error from the Bland-Altman plot is estimated to be 5 bpm. Similarly, outlier removal was applied to uterine contraction data, and both Fetal Lite and the CTG detected 19 true contractions.