Clinical Trials

As part of a rigorous clinical trial program, independently monitored using both GCP and ISO14155 guidelines, a number of clinical studies of the Monica AN24 have been initiated by Monica Healthcare for both CE and FDA regulatory approvals.  These include:

• 2007-2008: 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 40 patients were monitored, using the Monica AN24 simultaneously with both an FSE and IUPC during active labour.  The study was undertaken at the Department of Perinatology, Fertility and Gynaecology, University Medical Centre Utrecht, Holland. The lead clinical investigator was Professor G Visser. The results of this study have been published (see publications) and confirm both the safely and efficacy of the Monica AN24 as a home/hospital antenatal monitor.
• 2009:  A 100 subject L&D study comparing the Monica AN24 with Doppler FHR and ext TOCO uterine activity monitoring in the latent and active stages of labour through to delivery.  This study has resulted in a number of peer-reviewed publications with more to follow.  The study was undertaken at  Universität Witten / Herdecke, Germany. The lead clinical investigator was Dr Joscha Reinhard, MBBS, BSc(Hon) and the study was signed off by Prof Hatzman.
• 2009-2010: A 60 subject antenatal study comparing the Monica AN24 with Doppler FHR and ext TOCO uterine activity monitoring in the late second and third trimester.  This study has just (March 2010) completed recruitment and the data is being analyzed.  The study was undertaken at Universität Witten / Herdecke, Germany. The lead clinical investigator was Dr Joscha Reinhard, MBBS, BSc(Hon)
• 2010: A 40 subject L&D study comparing the Monica AN24 with simultaneous internal and external FHR and Uterine Activity monitoring.  This study is ongoing in a number of US institutions

In addition to these formal trials for regulatory requirements Monica Healthcare is also collaborating with a number of other trials including:

• Liverpool Women’s Hospital, UK: Lead Clinical Investigator, Professor Zarko Alfirevic. Home Induction of Labour, the effectiveness of current Tocolytic Therapy in PTL.  Beat to Beat HRV as a predictor of fetal outcome.
• Columbia University New York, USA: Lead Clinical Investigators Professor William Fifer and Professor Hein Odendaal.  True beat to beat HRV as a predictor of fetal well being.
• Utrecht University; Holland:  Lead investigator Professor G Visser.  Uterine activity as measured by EHG as a predictor of failure to progress during labour
• Milan University, Italy: Lead Clinical Investigators, Professor E Ferrazzi, Dr Tamara Stampalija.  Predicting the onset of PTL in a high risk population and a direct simultaneous comparison of Monica AN24 vs. the Avalon CTS system in mobilizing women during L&D.

Monica Healthcare has sold over 150 Monica AN24 devices over the past three years which are all being used in a diverse number of research studies.