Gian Carlo Di Renzo, MD

       “Hello everyone, my name is Gian Carlo Di Renzo.  I’m Professor of  Obstetrics and Gynecology and Perinatal Medicine at the University of  Perugia and now I’m also President of the European Association of  Perinatal Medicine.  Today I would like to talk to you about the new  frontiers of intrapartum fetal monitoring.  We have Professor Karl  Rosen, who is Chief Medical Director of       Neoventa.        

Professor Rosen has developed with coworkers new  methodologies for looking at intrapartum hypoxia better than before.   Now as many of you know, cardiotocography is the major tool for  intrapartum monitoring and monitoring the fetus in any condition during  labor.  Labor is a normal stressful condition but should be a natal  stress condition and not a distress condition from the fetus.  As you  know, cardiotocography has a lot of pitfalls due to the low sensitivity  and this is linked with the fact that we have increased a lot of  unnecessary intervention.  Therefore, we may probably increase all the  operative deliveries especially in some countries like in Italy and most  of the European countries will increase a lot of caesarian sections for  what we call fetal distress which is really not fetal distress.  Now in  the obstetrical arena many have looked to the possibility to improve  this methodology through computerized systems but I think the new age is  coming with new developments on the available use of fetal  electrocardiography.  Now Karl, can you just introduce briefly what the  basics of this new methodology are and how we can apply it for clinical  use?”
       
       

  “The aim  with this work that’s been ongoing for more than twenty-five years has  been to see if we could diagnose intrapartum hypoxia.  As you know, the  electrocardiogram provides very good information on the condition of the  heart under stress in the adult, and labor is a stressful so wouldn’t  there be ST waveform changes?  That was the theory some thirty years  ago, and then we’ve taken this concept through extensive animal work  performed in Sweden and in the UK and we said we need new technology to  be able to retrieve the ST.  We then had a series of devices named stand  units developed over the years.  Now with the latest development in  digital signal processing, we are able to present to the clinician the  information contained in the ST and there we are also using modern  expert system tools to guide the clinician in labor and the midwife as  well, thereby providing accurate information on the fetal state.  Now  just to touch on the physiology here...”
       
       

 “I think it is  very important that you express some of the basics about the ST waveform  - how you concentrate on that ST waveform because it so important for  myocardial action and for the evaluation of hypoxia.  Can you tell us  something about it?”
       
       

  “We have  here the electrocardiogram from the fetus.  Now the fetus is in a  situation where the majority are capable of responding to the stress of  labor.  What we then detect is an increase in T-wave amplitude as a  consequence of the use of myocardial glycogen stores.  These are stores  that nature has provided the fetus with and they are the most important  defense that’s available in labor.  What we are doing is we are  detecting the change by looking at T-wave height and we have a T upon  QRS ratio.  Then we’re also detecting the situation when the fetus is  not capable of responding and that’s where we see ST depression, they  get their T-waves.  We then let the computer go in and detect these  changes in labor providing direct guidelines of episodic changes,  baseline changes, and also these biphasic abnormal waveforms.  Here you  have examples of cases and this has now been tried in two randomized  control trials.”
       
       

 “So you are now  dealing with the randomized control trial and just recently a big  randomized control trial finished in Sweden and is going to be  published.  I think the results are very encouraging and in some way  definitely for the clinical application of this methodology in our  routine labor ward facts.  What do you have to say about this randomized  trial?”
       
       

  “It’s a  multicenter trial so we are talking about the three busiest units in  Sweden.  It’s a trial that’s gone on for eighteen months and 4,500  babies, and I’m very pleased to say that we have reduced the number of  babies suffering from intrapartum hypoxia by 75%.  If the technology has  been used accurately, no baby entered neonatal intensive care and,  furthermore, the number of operative interventions have been reduced by  45%.”
       
       

 “That is the aim  that we want to obtain.  I think everyone should know, but maybe they  don’t, that this system is applied to the simple scalp electrode we  normally use for the ECG tracing, internal tracing or when there is any  suspicious tracing by ultrasound or transabdominal monitoring of CTG,  you know everyone of us may decide to break the membranes and put a  scalp electrode to better understand what is going on in the fetal heart  rate beat.  In this case, we have an additional evaluation by a  computer system, which provides information that Karl Rosen has just  depicted for you.  The European union has funded a very big project  which Karl Rosen is a Project Leader and participating centers are all  around Europe.  I’m privileged to have the center in Italy to carry on  this research in which I think the aims are slightly different from a  randomized trial but not so very important because I think that we  support two major aims.  Can you tell us what are the major aims of this  European legal union trial we are already starting?
       
       

  “Yes, the  situation when something like this has been developed is that we want to  secure the safe use of this technology.  It is one thing when an  academic center develops something, but when an industry is producing a  machine I believe the most important thing is to make sure that it  actually works in clinical medicine.  Now what the EU Commission has  provided us with is one of the biggest grants and allowing us to set up  centers of excellence.  These are obstetric well-known centers that will  then be given a regional responsibility and serve as a hub of  experience.  Obviously every case will be monitored, and we’ll make sure  that the guidelines, which we have on the use of ST and CTG will be  followed and staff will be certified.  The aim with this is to enhance  obstetrics and make sure that the physiology that we believe is relevant  could be made full use of in labor in order to achieve the  extraordinary results of the Swedish Randomized Trial in providing a  better care for the women for the next…”
       
       

:  “I’d also like  to point out that  a normal cardiotocography machine a little bit better  shape, let’s say, according to the new wave of architectural design is  already on the market and is provided by a company in Goteborg, Sweden  called Neoventa Medical.  I think it can also be available in any of the  European countries.  It’s practically like buying a cardiotocograph  with the advantage you seem to have a more accurate evaluation of  intrapartum hypoxia and this is because we are dealing with the most  important organ that can be affected by intrapartum hypoxia, which is  obviously the heart.  So we’re going within the heart to look into the  myocardial function and from that we extrapolate the real value of these  ECG segments.  I think Professor Rosen has been very convincing and  also the result that’s been received and now human studies. This a new  frontier, I think in this way we may face the criticism to our  obstetricians to be not only very technological in their approach in the  labor ward and humanitarians and at the same time we’re increasing also  our subjugal approach.  We are closing the natural way of birth and due  to, I think, that fetal distress will be a very limited option in the  caesarian section area because it would be limited by the more accurate  evaluation.  So when there is fetal distress, it will be a real fetal  distress and not like it is now.  We do a lot of caesarian sections and  the baby comes out perfectly normal because obviously our  cardiotopography readings have been misleading or very low sensitivity  as it detects actually.  I think these add something really new and I  hope you interact with us at our       

 site.  If you have  any questions for Professor Rosen or me, please ask through the site.   We may interact a little and give you more of an explanation on this.   Thank you very much.”

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Gian Carlo Di Renzo, MD

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