Clinical Trials

As part of a rigorous clinical trial program independently managed by Mediqol using both GCP and ISO14155 guidelines, a clinical investigation of the Monica AN24 abdominal fetal and maternal Holter was undertaken at the Department of Perinatology, Fertility and Gynaecology, University Medical Centre Utrecht, Holland. The lead clinical investigator was Professor G Visser. A preliminary report on the trial findings was presented at the 8th WCPM, Florence, September 9-13, 2007 by Dr Margo Graatsma.

The primary objectives of the trial were:

• To demonstrate Essential Requirement I.3 of 93/42/EEC (MDD) i.e. that the device achieves the Performance (in terms of reliability and accuracy) intended by the manufacturer:
  • The Monica AN24 automatically extracts and reports FHR and MHR reliably from the raw abdominal electrophysiological recording for ≥ 70% of the time in ≥ 80% of patients during overnight recording.
  • The AN24 can automatically extract and report FHR and MHR accurately i.e. it has a correlation coefficient of ≥ 0.7 when compared with FHR which is manually extracted from the raw abdominal electrophysiological recording\ and (in the case of recordings during early labour) it has a correlation coefficient of ≥ 0.7 when compared with direct scalp fECG.
• To demonstrate Essential Requirement I.6 of 93/42/EEC (MDD) i.e. that any undesirable side effect must constitute an acceptable risk when weighed against the performances intended, specifically:
  • Demonstrate that the user and patient safety issues and potential adverse outcomes are as stated in the risk assessment

120 pregnant women (singleton pregnancies) with various gestational ages between 20 weeks and term were recruited and monitored using the Monica AN24 for fifteen (15) consecutive hours or more, including overnight. 42 subjects were monitored in the hospital and 78 at home. In addition a further 10 patients were monitored, using the Monica AN24 simultaneously with a conventional FHR monitor using a scalp clip, during labour.

In the trial the Monica AN24 exceeded performance requirements with respect to reliability and accuracy, and was demonstrated to be safe and well accepted by the subjects with no adverse outcomes:

Reliability

Over 86% of the 120 women monitored achieved an overnight success rate of 70% or more. Only gestation, shown below, correlated with success rate. Factors such as BMI, presentation, and location (home/hospital) did not impact on the success rate.

Overnight success rates, based on the 2-second average FHR, plotted as a function of gestation. MHR success rate was never lower than 98%

Accuracy

Spot-checks covering 1 minute of ECG samples were taken at 60 minute intervals throughout the recording (starting at time T=0). A software application allowed the analyst to 'mouse-click' on successive FECG R-wave peaks within the sample to generate the FHR manually. This manually derived FHR trace was then compared with that automatically derived by the Monica AN24 to check for accuracy. This was done in 74 recordings, with an overall correlation of 0.84 and SD of 0.1, gestation, location (home/hospital), BMI and presentation did not impact on accuracy.

In addition, the accuracy of the Monica AN24 was also compared with direct scalp FECG in 10 Patients in Labour. The average beat-to beat FHR correlation is 0.92 and an example is shown below.