Can you tell us about your first experiences of STAN and ST Analysis?

ST Analysis was introduced to St. George’s Hospital by my predecessor Mr. Austin Ugwumadu and Professor Sir Sabaratnam Arulkumaran in 2002. Initially we had only four STAN ST machines and hence had to prioritise its use for specific clinical situations (e.g. meconium stained liquor, previous caesarean sections etc.). We soon realized that in order to benefit from the technology, we needed to train our staff appropriately and use the device more often to gain experience and expertise. This was the beginning of our learning curve. In 2004 a midwife, who was experienced in ST Analysis was hired to work halftime with research and education and halftime clinically on the labour ward. This immensely helped obstetricians and midwives to develop the knowledge and skills to use and interpret this technology.

You published the results of your first 1500 cases¹. Can you tell us about the experience you describe in the article?

We identified 14 babies who were monitored using ST Analysis but had poor outcomes. On analysis, the poor outcomes were all related to human factors. The human errors included lack of knowledge (e.g. failure to recognise a pre-terminal CTG trace), failure to incorporate the clinical picture (such as intrapartum pyrexia, fresh thick meconium, and sentinel hypoxic events during labour) and failure to follow STAN Guidelines including failure to take appropriate action and delays in action.

Once we had looked at the outcomes and realised the cause of these poor results, we instituted several measures to reduce human error. These included intensive training for all midwives and doctors, training and assessment of competencies for all new staff joining our department, instituting a central monitor for ‘fresh eyes approach’. The STAN-specialist midwife was employed, and arranged mandatory training and study days for all staff, including certification for both midwives and doctors. We set up a database for all cases so we could easily keep track of our results and follow up all cases that had a poor outcome in
weekly case discussions.

Now we are in 2011 and you have gained a lot more experience. Can you describe how you work with the STAN-method today?

We have 19 STAN ST monitors in the labour ward and we have continued to work very actively with this technology. There is greater interaction between obstetricians and midwives to continuously improve knowledge and outcomes.

An Intrapartum Fetal Monitoring Group at St. George’s has been established, and it constitutes of Prof. Sir Arulkumaran, Mr. Ugwumadu, midwife Gini Lowe and myself. We were the first hospital in the UK to have implemented a Policy on Competency in Electronic Fetal Monitoring in Labour to achieve a minimum 85% competency in the Assessment and to have a support system for those who do not achieve this level of competency.

We strongly believe that unlike fetal blood sampling (either for pH or lactate) and fetal pulse oximetry which look for peripheral acidosis, ST Analysis looks at a central organ, i.e. the fetal heart. It is therefore the best technology currently available for intrapartum fetal heart rate monitoring.

Our caesarean section rates (19-23%) are the lowest among all teaching hospitals in London (average 28-32%) and we believe STAN ST has immensely contributed to our lower caesarean section rate. In 2010 we only performed one fetal blood sampling in 5500 deliveries.

Our team continuously organise education and training course in fetal monitoring during labour, both in our own hospital and in other hospitals in the UK.

1. Doria V, Papageorghiou AT, Gustavsson A, Ugwumadu A, Arulkumaran S Review of the first 1502 cases of ECG-ST waveform analysis during labour in a teaching hospital. BJOG 2007;114:1202-1207.

The complete article is now available FREE of charge on the Obstetrics & Gynecology webpage here.

For more information, please read the full press release in PDF-format here.

For more information, please read the full press release in PDF-format here.

Updated: Read the full article "Reduced prevalence of metabolic acidosis at birth:..." for free (ePrint)

The study included 5 681 high risk patients, randomly assigned to either monitoring by CTG or CTG+ST Analysis. The primary outcome of the study was metabolic acidosis, defined as pH < 7.05 and Base Deficit in extracellular fluid (BDecf) > 12mmol/l. The result also includes metabolic acidosis calculated in blood (BDblood). Other secondary outcomes were operative deliveries, Apgar scores, admissions to NICU and number of FBS.

There was a 30% reduction of metabolic acidosis in the CTG+ST Analysis group. When base deficit was calculated in blood there was a significant reduction in metabolic acidosis with 44 %. At the same time, there was a 48% reduction in the use of FBS in the CTG+ST arm. These effects were achieved without any increase in operative deliveries. There were no effects on other neonatal outcomes. These results are consistent with the results of the meta-analysis of earlier randomised trials published in the Cochrane report.

The Dutch RCT was powered on the assumption that 3.5% of newborn would have metabolic acidosis at birth. In reality, the rate was much lower (1.1% in the CTG arm and 0.7% in the CTG+ST Analysis arm), explaining why the 30% reduction in primary outcome, although substantial, did not reach statistical significance. The 44% reduction in the metabolic acidosis in blood was however significant.

There is no consensus which method to use for calculating base deficit and metabolic acidosis: in the intracellular fluid or in blood. Researchers mostly use the first method, while in clinical practice the second is most common (since it is automatically calculated by most blood gas analysers). Both methods showed a substantial reduction of metabolic acidosis in the CTG+ST arm.

The Dutch RCT is one of the largest trials ever within obstetrics. It was performed in nine centres: three academic hospitals and six non-academic teaching hospitals. Most hospitals in the study did not have any previous experience of STAN. The study was performed without any involvement from Neoventa.

Reading, MA -- Neoventa Medical, Inc., a medical device company that has developed proprietary software that is used as an adjunct to electronic fetal monitoring to determine whether obstetrical intervention is warranted when there is increased risk of the fetus developing metabolic acidosis during labor and delivery, announced the appointment of Marilyn Lapidus as Vice President. Ms. Lapidus will focus on sales, marketing, and business development for the USA. "I am very pleased that we have been able to add an exceptionally talented professional to the management team at Neoventa," said Jan Stålemark, President and CEO. "Marilyn has spent the last 30+ years focused on the care of the mother and fetus. Her skills will complement our team's expertise as we position our company for growth in the United States."

Prior to joining Neoventa, Ms. Lapidus was Director of Marketing at GE Healthcare, Maternal Infant Care, in the Maternal Fetal Care segment. She brings a wealth of marketing, product development, clinical research, continuing education, business development, and sales experience to this position. Before its acquisition by GE, Ms. Lapidus was Director of Clinical and Scientific Affairs for Marquette Medical Systems, which had previously acquired Corometrics Medical Systems. She is recognized worldwide as an authority on maternal/fetal monitoring with three (3) publications and has frequently participated in seminars and symposia on high-risk obstetrics. Ms. Lapidus earned a JD from the University of Connecticut School of Law and a BS in Nursing from Boston University.

"Marilyn joins us at an important time in Neoventa's growth as a company. Her expertise in this market segment, and her skill set and personal relationships with so many of the key opinion leaders will be especially helpful to our strategy for business development and plans for growing our market share in the United States” stated Mr. Stalemark.

About Neoventa Medical, Inc.

The purpose of the study was to evaluate the cost-effectiveness of ST analysis compared to that of CTG alone. The authors used a decision model with baseline estimates derived from the literature. The result shows that ST analysis is a cost saving method compared to CTG alone in the long term perspective, including immediate direct treatment costs at the hospital and the lifetime costs for individuals with severe cerebral palsy. In the short term, when considering only the treatment costs associated with the immediate care at the hospital, the study also shows that ST analysis is cost saving. This means that the additional cost using the ST analysis device instead of CTG is more than outweighed by the cost saved avoiding caesarean sections, instrumental vaginal deliveries, cases of metabolic acidosis and cases of encephalopathy.The authors conclude that ST analysis is the cost-effective alternative since the use results both in a gain in quality-adjusted life years (QALYs) and in a lower cost, thus ST analysis is dominating over CTG alone.

Read the article here.

Order the thesis from Neoventa

For more information, please see the press release here.

Read the UCSF Fresno press release here.

For more information, please see the press release here.

Doria V, Papageorghiou AT, Gustavsson A, Ugwumadu A, Arulkumaran S.

BJOG 2007;114:1202-1207

The aim of this study was to evaluate and report the strengths and weaknesses of introducing CTG-ST analysis during labour in a teaching hospital set up. St George’s Hospital in London has over 4,000 deliveries per year and is a regional tertiary referral centre for perinatal medicine. STAN was first introduced in June 2002, and 1,502 women out of 14,890 were monitored until December 31, 2005. In 56% of the cases, umbilical cord blood gases were available. During the study period there were 35 cases (0.27%) with neonatal encephalopathy, out of which 14 were monitored with STAN. The retrospective analyse of these 14 cases highlights the continuing problem of poor CTG interpretation, delayed action and non-adherence to guidelines. The authors conclude that better training in CTG and ST analysis, assessment and supervision of users may help improve outcome.

Seppo Luode, MBA, MSc, has extensive experience from international business development and strategic planning in patient monitoring and other medical equipment and clinical information systems companies with focus on strategic marketing, acquisitions/divestments and alliances.

Dan Pitulia, CEO, Carmel Pharma, has extensive international experience from both FMCG and medical devices companies with focus on entrepreneurial management for high growth. Past challenges and successes include turnarounds, LBOs, IPO and industrial exits.

We welcome our new board members to the work with Neoventa and STAN and upcoming, very inspiring challenges.

Devoe LD, Ross M, Wilde C, Beal M, Lysikewicz A, Maier J, Vines V, Amer-Wåhlin I, Lilja L, Norén H, Maulik D. Am J Obstet Gynecol. 2006;195, 729–734.

This is a prospective, non-randomized study enrolling 530 patients from diverse populations and providers in six university and community medical centres. It is the first clinical usage study of STAN in the US. The objective of the study was to show that US obstetrical staff, once trained, can appropriately interpret and apply the STAN system. The study included a structured training program and a pilot and credentialing phase before the actual clinical use. The results of the study demonstrated that the STAN system can be applied to support obstetric decision making and that unneeded interventions for non reassuring fetal heart rate can be safely avoided. The authors conclude that US clinicians can use the STAN system effectively and in a manner similar to that of experienced STAN users.

This is a prospective observational study of the introduction of the STAN methodology in two maternity wards during two years in the city of Goteborg, Sweden. Out of the total population of 14,687 term deliveries, 4,830 were monitored using STAN. The units were equipped with 8 STAN units with an additional 3 units the last 6 months of the study. The usage of STAN increased from 28.1% the first year to 37.7% the second year and was associated with a significant reduction in metabolic acidosis in the total population from 0.76% to 0.44% respectively. The rate of operative deliveries in the total population did not change during the study period.

Norén H et al. STAN in clinical practice – The outcome of 2 years of regular use in the city of Gothenburg. Am J Obstet Gynecol 2006;195:7–15.

Read abstract

See the press release in English, sent out on June 19, 2006.

See the press release in English, sent out on June 19, 2006.

We are very proud to receive this honour and intend to continue this level of growth.

See the US version of the press release, sent out on November 2, 2005.

■ By CHRISTIAN THYE-PETERSEN

After nine months of waiting, sudden problems for the baby – and nervous glances from the doctor – are the last thing a couple to soon become parents wishes for when the moment is soon to come. Experiences of a new device at among others Rigshospitalet and Gentofte Amt Hospital gives hope that this will happen less often.

Rigshospitalet have now for almost one year - Gentofte a little longer - used the so called STAN device that effectively shows the condition of the fetus heart during labour. And the result is that the number of babies with oxygen deficiency has been halved. During a period of eight months there were 50 % less babies over 36 weeks gestation born with a critically low pH value in the umbilical cord. If the pH in the umbilical cord is below a certain value there is an increased risk for the baby to develop seizures and brain damage. If this tendency remains, the number of babies with oxygen deficiency at Rigshopsitalet will decrease from 55 last year to 27 this year.

"With this device we have an extra parameter for assessing the condition of the fetus. This means that we with greater accuracy can decide if we should "take out" the baby immediately or keep our hands off and let nature have its course" says Thomas Bergholt from the labour ward at Rigshospitalet.

When things have to move fast

The new device shows an electrocardiogram and has a built in computer that interprets the ECG and gives the doctors "prepared" information so that they themselves do not need to interpret the ECG. It is used as a supplement to the so called cardiotocograph technology that women in labour have been acquainted with during the last 30 years.

"CTG technology has been shown to have limitations. We have to say that it was never as effective as it was expected to be when it was first introduced. Now that we have the STAN device it means that parents more seldom will be exposed to the very unpleasant situations when everything suddenly has to move very fast" says Thomas Bergholt.

Rigshospitalet has received the eight devices through a foundation and the current experiences will be discussed at a meeting on Wednesday with participants from the entire country.

Blood tests

The device has been accessible in Europe since 2001 but is only implemented in a few hospitals in Denmark, among others in Horsens, Svendborg and Aalborg. A large Swedish trial including 5,000 women in labour showed results comparable to the practical experiences from Rigshospitalet and Gentofte Amt Hospital.

"The thing is that it is expensive to introduce in the hospitals. It is not just the cost of the device, it is also necessary with thorough training of the staff that will use the device. But it is my experience that it is very useful for both us and the women in labour. The discussion is whether you will get as good results from a method where you take a blood test from the head of the baby" says Thomas Bergholt.

Translation from the article "Nyt udstyr hindrer iltmangel ved fødsel" published in the Danish newspaper Jyllands-Posten, August 17, 2005.

© Jyllands-Posten, 2005

On June 23 the team from Neoventa together with the American investigators in the STAN application multi-centre study presented their case in front of the FDA expert panel in Washington. The panel unanimously recommended FDA to approve STAN for use in the USA.

- This type of approval places extremely high demands on a company to show product safety, efficacy and useability which is the reason why it is so seldom that new device of this type are approved by the FDA. We are very happy with the result, Simon Grant commented after the meeting. We will now work with the FDA to finalize the approval, hopefully by the end if this year.

Enclosed is the US version of the press release sent out on June 28, 2005.