When we made the decision to implement ST Analysis, we were very much focused on education and training. Before going live with the method all 160 midwifes and doctors went through theoretical and practical education and became certified Stan users. Right from the start regular sessions for retrospective case discussions have been part of a continuous learning process.

And was the implementation successful?

Yes, very successful. It was worthwhile spending efforts on education already from the start. We believe it reduced the risk of deliveries with adverse outcome due to staff not understanding the methodology or not following the guidelines.

From the start we also created a simple research form, a CRF to register all Stan cases in order to be able to follow-up our performance. We recently published our 5-years results that include over 6,000 high risk cases monitored with ST Analysis.

Over the five years, our usage of ST Analysis increased and was by the end of the study period almost 34 %. The proportion of cord metabolic acidosis cases decreased with 79% over the study period, and at the same time the overall cesarean delivery rate also decreased.

You gave a presentation at the Nordic Congress of Ob/Gyn in June about how you have organised your data collection. Can you tell us about that?

All our Stan monitors are connected to Ethernet, which is the requirement for digital archiving of the recordings. This makes it possible to organise a digital library of Stan recordings for retrospective analysis, education and research. We can find and open any specific recording at any time at any connected hospital computer and look at the file with Stan Viewer software.

For the antepartum observation of high risk patients we use Stan monitors equipped with the STV feature. These recordings are of course stored digitally as well, which simplifies the assessment and signing.

We also use the Stan Viewer Live program, which allows us to look at on-going recordings in real time from any of the hospital computers. When you are called, you can assess the on-going recording from your office within seconds and decide whether to go to the labour ward immediately or not. It has also become easy to discuss on-going recordings with colleagues outside the delivery room. All our staff is very content with these programs which have simplified our work flow considerably.

With 5300 employees and 1000 beds the Isala hospitals in Zwolle is one of the largest clinical top hospitals in the region. The mission of the hospital is quality, attention and a personal relationship with the patient. The hospital has around 3300 deliveries per year in the nine delivery rooms.

Dr. Mantel, the Head of Obstetrics, tells us that it is seldom that the clinic refers patients to an academic centre. The Isala hospitals have both a second-line and a third-line obstetric function with nine beds for high risk care and facilities for advanced ultrasound and prenatal diagnostics.

“We have nine delivery rooms and our aim is to perform intrapartum monitoring in a standardised way. This is the reason why choosing Stan for all our rooms.”

The Isala Hospital recently made an additional purchase of Stan monitors. They now have eighteen Stan-units and as of today nine of them are with ST Analysis. Dr. Mantel explains that CTG only is not an option, it is not sufficient as monitoring method. There is always a need for a complementary method, and the choice stand between fetal blood sampling and ST Analysis.

“Fetal blood sampling is both technically difficult and a patient unfriendly procedure, while ST Analysis is both reliable and a patient friendly method for intrapartum fetal monitoring.”

Dr. Mantel believes that Stan will show to be cost effective in the long run, when the cost for fetal blood sampling will be saved. But this is not the reason for the purchase of the Stan monitors.

“It’s all about patient friendliness. This is the most important factor in the practice of obstetrics today.”

Dr. Mantel, Mr. Wansing, Dr. Dijkstra, Mr. Fransen, Mrs. Voortman and a Stan monitor at Isala Hopsital.

See the poster

A total of 2459Stan recordings from two earlier published studies were included in the evaluation. The recordings were divided into three groups depending on outcome; 88.3% had an uncomplicated delivery, 8.9% ended in an operative delivery due to suspected fetal distress and 2.8% of the neonates had an adverse outcome. No statistically significant differences in mean T/QRS baseline could be identified between the three groups.

The authors state that they did not find any arguments in favour of using high baseline T/QRS at the start of the Stan recording as a predictor for adverse neonatal outcome or intervention for fetal distress. In addition they conclude that the current Stan guidelinesare still suitable, and that local Stan guidelines that are extended to include recommendations regarding high T/QRS baseline should be adjusted.

Abstract

Acta Obstet Gynecol Scand. 2012 Feb;91(2):189-197

Predictive value of the baseline T-QRS ratio of the fetal electrocardiogram in intrapartum fetal monitoring: a prospective cohort study.

OBJECTIVE:
To evaluate the added value of the baseline T/QRS ratio to other known risk factors in predicting adverse outcome and interventions for suspected fetal distress.

DESIGN:
Prospective cohort study.

SETTING:
Three academic and six non-academic teaching hospitals in the Netherlands. Population. Laboring women with a high-risk cephalic singleton pregnancy beyond 36 weeks of gestation. Methods. We obtained STAN® recordings (ST-analysis, Neoventa, Sweden) from two previous studies. Three patient groups were defined: cases with adverse outcome, cases with emergency delivery because of suspected fetal distress without adverse outcome, and a reference group of uncomplicated cases. Baseline T/QRS ratios among the adverse outcome and intervention for suspected fetal distress cases were compared to those of the uncomplicated cases. The ability of baseline T/QRS to predict adverse outcome and suspected fetal distress was determined using a multivariable logistic model.

MAIN OUTCOME MEASURES:
The added value of the baseline T/QRS to other known risk factors in the prediction of adverse outcome and interventions for suspected fetal distress.

RESULTS:
From 3462 recordings, 2459 were available for analysis. Median baseline T/QRS for uncomplicated cases, adverse outcome and interventions for suspected fetal distress were 0.12 (range 0.00-0.52), 0.12 (0.00-0.42) and 0.13 (0.00-0.39), respectively. There was no statistical difference between these groups. Multivariable analysis showed no added value of baseline T/QRS in the prediction of either adverse outcome or interventions for suspected fetal distress.

CONCLUSION:
Baseline T/QRS has no added value in the prediction of adverse neonatal outcome or interventions for suspected fetal distress.

The random effects model* was used to estimate the combined relative risk. A relative risk less than 1 indicates an effect in favour for ST Analysis.

In previously reported meta-analysis’ in the Cochrane Database, fixed-effects analysis have been used. When this model was used for the five RCTs with converted data, the reduction in metabolic acidosis became significant.

The authors conclude that intrapartum monitoring with ST Analysis is a safe method and that its implementation can lead to a reduction in operative deliveries as well as the need for fetal blood sampling. The incidence of metabolic acidosis is reduced across a majority of the studies but reaches significance only when the fixed effects model is used. Due to the among-study differences on the effect of metabolic acidosis, the authors question if this is the right outcome to investigate, but other more specific perinatal outcomes are however very rare. They also conclude that since ST Analysis reduces both the intervention rate for suspect fetal distress and the total intervention rate, this indicates that ST Analysis has a true effect on the mode of delivery and lowers the risk of operative delivery.

*A random-effects model use estimates of the within study variances as well as estimates of the among study variances.

Abstract

Obstet Gynecol. 2012 Jan;119(1):145-154.

ST Analysis of the Fetal Electrocardiogram in Intrapartum Fetal Monitoring: A Meta-Analysis.

Becker JH, Bax L, Amer-Wåhlin I, Ojala K, Vayssière C, Westerhuis ME, Mol BW, Visser GH, Maršál K, Kwee A, Moons KG.

From the Departments of Obstetrics and Gynecology, University Medical Center Utrecht, Utrecht, the Netherlands, Oulu University Hospital, Oulu, Finland, University Medical Center, Toulouse, France, Amsterdam Medical Center, Amsterdam, the Netherlands, and Lund University, Lund, Sweden; the Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, the Netherlands; Pharsight, A Certara Company, Sunnyvale, California; and the Department of Women and Child Health, Karolinska Institute, Stockholm, Sweden.

OBJECTIVE:
To compare the effects of ST-waveform analysis in combination with cardiotocography with conventional cardiotocography for intrapartum fetal monitoring.

DATA SOURCES:
We searched MEDLINE, Embase, and PubMed for randomized controlled trials (RCTs) evaluating ST-waveform analysis for intrapartum fetal monitoring.

METHODS OF STUDY SELECTION:
We identified RCTs that compared ST-waveform analysis and conventional cardiotocography for intrapartum fetal monitoring of singleton pregnancies in cephalic presentation beyond 34 weeks of gestation and evaluating at least one of the following: metabolic acidosis, umbilical cord pH less than 7.15, umbilical cord pH less than 7.10, umbilical cord pH less than 7.05, umbilical cord pH less than 7.00, Apgar scores less than 7 at 5 minutes, admittance to the neonatal intensive care unit, need for intubation, presence of hypoxic ischemic encephalopathy, perinatal death, operative delivery, and number of fetal blood samplings.

TABULATION, INTEGRATION, AND RESULTS:
Five RCTs, which included 15,352 patients, met the selection criteria. Random-effects models were used to estimate the combined relative risks (RRs) of ST analysis compared with conventional cardiotocography. Compared with conventional cardiotocography, ST analysis showed a nonsignificant reduction in metabolic acidosis (RR 0.72, 95% confidence interval 0.43-1.19, number needed to treat [NNT] 357). ST analysis significantly reduced the incidence of additional fetal blood sampling (RR 0.59, 95% confidence interval 0.44-0.79, NNT 11), operative vaginal deliveries (RR 0.88, 95% confidence interval 0.80-0.97, NNT 64), and total operative deliveries (RR 0.94, 95% confidence interval 0.89-0.99, NNT 64). For other outcomes, no differences in effect were seen between ST analysis and conventional cardiotocography, or data were not suitable for meta-analysis.

CONCLUSION:
The additional use of ST analysis for intrapartum monitoring reduced the incidence of operative vaginal deliveries and the need for fetal blood sampling but did not reduce the incidence of metabolic acidosis at birth.

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.

For more information, please see the press release here.

Read the UCSF Fresno 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.