Delivering Success!!

Clinical Trials

The total number of subjects collected was:

  • 135 uterine activity subjects
  • 71 Fetal Heart Rate subjects

Results and Conclusions

Our clinical trial used three primary end points to demonstrate the effectiveness of the LaborView device for assessing Uterine Activity.  These were Positive Percent Agreement, Sensitivity, and Timing Accuracy.  The hypotheses for Positive Percent Agreement and Sensitivity were non-inferiority hypotheses when compared to the Tocodynamometer, and for the Timing Accuracy, the hypothesis was equivalence when compared to the Tocodynamometer.

For both Positive Percent Agreement and Sensitivity, the LaborView device demonstrated superiority to the Tocodynamometer and thus also demonstrated non-inferiority (P<0.0001 for both PPA and Sensitivity).  The data was also analyzed for patients with a BMI ≥ 30.  For both endpoints, the LaborView device was superior to the Tocodynamometer device for patients with a BMI ≥ 30, and thus also was also non-inferior to the Tocodynamometer device (again, P<0.0001 for both PPA and Sensitivity).

In the analysis of the Timing Accuracy, for all patients and patients with a BMI ≥ 30 the LaborView device was equivalent to the Tocodynamometer device.

There were two primary endpoints used to demonstrate the effectiveness of the LaborView device to assess Fetal Heart Rate parameters.  These were Positive Percent Agreement and Root Mean Square Error (RMSE).  For both endpoints the hypothesis tested was a non-inferiority hypothesis to Ultrasound Device outcomes.

For both endpoints, the superiority of the LaborView device to Ultrasound was established and thus the non-inferiority was also demonstrated (P<0.0001 for both PPA and RMSE).  The data was also analyzed for patients with a BMI ≥ 30.  For both endpoints, the LaborView device was superior to the Ultrasound device for patients with a BMI ≥ 30, and thus also was also non-inferior to the Ultrasound device (again, P<0.0001 for both PPA and RMSE).

 

Future Clinical Trials:

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