Expectations

To help you in understanding Monica’s innovative technology, we’ve prepared a list of expectations. If you have a question please contact us.

FHR Accuracy

In clinical studies it was shown that Monica AN24 rarely confuses MHR with FHR. Overall, possible MHR/FHR confusion was less than 0.36% compared to 8.9% for Doppler FHR^{1 2}.

FHR Reliability

Monica AN24 does not work in all women all of the time. Failure is not based on BMI^{3 4 5}, but can be influenced by patient movement and posture. It may be necessary to swap during the first or second stage to an alternative modality, see 'Confidence' below.

Confidence

Monica AN24 does not coast and rarely inserts false FHR values¹. Like FSE, when FECG signal is lost no sound is generated and there is silence. If a FHR gap occurs for longer than 5 minutes the user should consider confirming FHR with another modality, or swapping to another modality, depending on the clinical situation.

Training

Practise at preparing skin and placing electrodes is required before FHR and UC can be successfully monitored.

UC Detection

In clinical studies Monica AN24 successfully detected 87% of all contractions with respect to IUPC, compared to only 55% for TOCO⁶. Like TOCO, Monica UC does not indicate the contraction strength or hypertonus, and can introduce small false positive contractions when compared with IUPC.

1 "Accuracy and Reliability of Fetal Heart Rate Monitoring Using Maternal Abdominal Surface Electrodes", Wayne R. Cohen et al, Submitted to Obstetrics & Gynecology (under review), August 2011

2 "Maternal and fetal heart rate confusion during labour", Bhogal.K, Reinhard.J, British Journal of Midwifery. Vol 18, No, 7: 424-428. July 2010

3 "Clinical Investigation Report – Fetal Heart Rate and Uterine Activity during Labor and Delivery For Patients ≥37 Weeks gestation", Monica Healthcare Document 100-CT-043, submitted to FDA to support K101801

4 "Maternal Body Mass Index Does Not Affect Performance of Fetal Electrocardiography", Graatsma EM, Miller J, Mulder EJ, Harman C, Baschat AA, Visser GH. Am J Perinatol. 2010 Aug;27(7):573-7. Epub 2010 Mar 1.

5 "The equivalence of non-invasive foetal electrocardiogram (fECG) to Doppler cardiotocogram (CTG) ultrasound during the 1st stage of labour", Reinhard J, Hayes-Gill BR, Yi Q, Hatzmann H, Schiermeier S.. J Perinat Med, 38 (2010)

6 "510(k) summary for K101801", FDA 510(k) summary of clinical trial on Fetal Heart Rate and Uterine Activity during Labor and Delivery For Patients ≥37 Weeks gestation (summary of [iii]