Clinical Evidence
Multiple studies published in peer-reviewed journals all demonstrate the same thing:
TrueLaborTM Technology is safe, accurate, fast and easy to learn, use and adopt. It provides a measure of safety that is unavailable with today’s technology.
The evaluation of uterine activity is an important aspect of labor monitoring. It may aid in the detection of non-reassuring fetal heart rate (as decelerations are defined in relation to contractions), evaluation of power in scenarios of protracted or arrested labor and diagnosis of true preterm labor. The currently available methods lack key elements of uterine activity monitoring. The use of TrueLaborTM Technology rather than TOCO or IUPC allows overcoming the disadvantages of invasive monitoring by IUPC and semi-quantitative monitoring by TOCO, while ascertaining the ability to quantify uterine activity for frequency, duration and intensity of contractions in a safe, non-invasive and accurate method that can be performed throughout pregnancy and during all stages of labor.
Peer Reviewed Scientific Papers
Saila S. Moni, MD; Rachel Kirshenbaum, MD; Lizelle Comfort, MD; Kfier Kuba, MD; Diana Wolfe, MD;
Xianhong Xie, PhD; Abdissa Negassa, PhD; Peter S. Bernstein, MD
American Journal Of Obstetrics & Gynecology Maternal-Fetal Medicine, 3(4):100375, July 2021
Objective
This study aimed to validate the accuracy of electrical uterine myography by comparing it with tocodynamometry and intrauterine pressure catheters among laboring patients with obesity.
Results
Electrical myography was significantly more interpretable during a 30-minute tracing and detected 39% more contractions than tocodynamometry, whereas there was no difference in the interpretability of tracings or number of contractions between electrical myography and an intrauterine catheter. Patients who underwent simultaneous monitoring preferred the electrical myography device over tocodynamometry.
Conclusion
Electrical uterine myography is superior to tocodynamometry in the detection of intrapartum uterine contraction monitoring and comparable with internal contraction monitoring.
Deepika Sagaram, Kavita Vani, Kfier Kuba, Calvin Lambert, Xianhong Xie, Peter S. Bernstein
American Journal Of Obstetrics & Gynecology, 222(1):403-404, Jan 2020
Objective
We aim to investigate the clinical utility of a novel noninvasive abdominal fECG device as compared to the standard of care Doppler ultrasound cardiotocography (CTG) in obese patients.
Results
Monitoring with the devices simultaneously yielded a total of 1303.66 minutes of tracing. Overall, the fECG device was no different in its ability to detect baseline FHR, variability, and number of FHR accelerations/decelerations.
Conclusion
In most parameters of FHR tracing, it performed similarly. Given that the noninvasive fECG device is wireless and therefore allows ambulation, consideration should be given to its use as an alternative to Doppler CTG.
Saila S. Moni, Rachel Kirschenbaum, Lizelle Comfort, Kfier Kuba, Diana Wolfe, Xianhong Xie, Abdissa Negassa, Peter S. Bernstein
American Journal Of Obstetrics & Gynecology, Volume 220, Issue 1, Supplement, S255, January 2019
Objective
This study aimed to validate the accuracy and clinical usefulness of the EUM device by comparing it with simultaneous use of IUPC among laboring patients.
Results
A total of 68 patients were monitored for 2,749 minutes via simultaneous EUM and IUPC devices: 80.8% patients were obese. 82.35% of the patients were receiving oxytocin at the time of the recordings and 98.5% had epidurals. On average, the EUM was no different with regards to interpretability/continuity when compared to IUPC on a 30-minute tracing. This finding was similar among obese and nonobese women. Overall, EUM was no different in its ability to detect contractions among obese and non-obese patients. 84% of the patients preferred the EUM device over the IUPC.
Conclusion
Given that the EUM device is noninvasive and can also monitor contraction strength, future noninferiority studies should be conducted to determine if the EUM device can replace IUPC monitoring.
Saila S. Moni, Rachel Kirschenbaum, Lizelle Comfort, Kfier Kuba, Diana Wolfe, Xianhong Xie, Abdissa Negassa, Peter S. Bernstein
American Journal Of Obstetrics & Gynecology, Volume 220, Issue 1, Supplement, S255-256, January 2019
Objective
This study aimed to validate the accuracy of an external device which monitors uterine electrical activity by comparing it to tocodynamometry among obese patients.
Results
A total of 65 obese patients were monitored via simultaneous EUM and TOCO devices. The average gestational age was 39.0 weeks with 66.15% patients in latent labor. 53.85% patients were receiving oxytocin at the time of the recordings and 69.3% patients had epidural. On average, the EUM was 1.49 minutes more interpretable/continuous in a 30 min tracing. Overall, EUM detected 39% more contractions in a 30 min tracing compared to TOCO. With regards to patient preference, 64.62% patients undergoing simultaneous monitoring preferred the EUM device over the TOCO.
Conclusion
Given the challenges of using a tocodynomameter with obese women, consideration should be given to replacing it with the EUM device, which appears to be more sensitive and accurate and preferred by patients.
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