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.

Tahira Kazmi, Forough Radfer, and Sultana Khan. Oman Med J. 2011 November; 26(6): 459–460.

Click here to read the article

See the poster

The objective of this retrospective studywas to evaluate if the value of the baseline T/QRS ratio could be used to predict intrapartum asphyxia. High baseline T/QRS ratio was defined as ≥0.25 or ≥2 SD from the mean.

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.

Click here to read the article

Neoventa also recommends the use of some automated backup for the disk or folders where the server stores the recording data.

Configure STAN for IP networking as described above, and validate the network settings using the System Status dialog.

Set the STORAGE_DEVICE setting to match the server type, either FTP, HTTP/ WebDAV or HTTP/POST.Set the NETWORK_STORAGE_URL to point out the network node where the server is located, e.g. ftp://192.168.0.0 (or http://192.168.0.0) if the server is located on the fixed IP address 192.168.0.0. If DNS (Domain Name System) is configured, it is recommended to use the name of the server instead of the IP address, e.g. ftp://example.com or http://example.com. If the recordings are to be placed in a specific sub-folder on the server, this can also be specified in the URL, e.g. ftp://example.com/STAN/ or http://example.com/STAN/, if the recordings are to be placed in sub-folder STAN.Then specify the user account that STAN shall use when logging on to the server, by setting the NETWORK_STORAGE_USERNAME and NETWORK_ STORAGE_PASSWORD settings. If these are left empty, STAN will use “anonymous”  for username and “User@STAN” for password when authenticating against an FTP server.

To validate the network storage settings, select the Network Storage Control button to enter the Network Storage Control dialog. Make sure the network cable is properly attached, and then select the Test button. STAN then tries to connect to the defined server, and tests different types of operations that are needed to be able to store recordings. In order for Network Storage to function properly, STAN must have permission to create sub folders and create new files on the server. During a test, a folder (Safe_to_delete_NNNN) is created and a text file (Safe_to_delete_ NNNN.txt) is uploaded to this folder. You may delete these from the server after the test.

If the configuration is correct, STAN will upload finished recordings in chronological order as a background task during ongoing recordings. It is also possible to start the storage procedure by selecting the Start Storage button in the Network Storage Control dialog.

One hundred eighty women with a full-term, singleton, cephalic presentation and a CTG tracing with non-reassuring fetal heart rate (NRFHR) were included in the study. The rate of caesarean delivery, indication for operative delivery due to NRFHR and neonatal acid-base status was compared between the groups.

The study showed a significant difference in mode of delivery, in that the rate of caesarean section was 37% lower in the group monitored with ST Analysis. The authors conclude that both methods can prolong labour in situation with NRFHR, but that ST Analysis was more effective in safely avoiding emergency caesarean deliveries, and that this method also provided a more continuous source of information on fetal status throughout labour.

Abstract

Eur J Obstet Gynecol Reprod Biol. 2011 Oct 4. [Epub ahead of print]

Effectiveness of pulse oximetry versus fetal electrocardiography for the intrapartum evaluation of nonreassuring fetal heart rate.

Valverde M, Puertas AM, Lopez-Gallego MF, Carrillo MP, Aguilar MT, Montoya F. Obstetrics and Gynecology Service, Santa Ana Hospital, Motril, Granada, Spain.

OBJECTIVES:
To compare the effectiveness of pulse oximetry and fetal electrocardiography in the management of labor with nonreassuring fetal heart rate (NRFHR).

STUDY DESIGN:
This randomized experimental study consisted of two arms. In group 1 we used pulse oximetry and in group 2 we used STAN® technology. The participants in each group were 90 pregnant women with a full-term singleton fetus in cephalic presentation and cardiotocographic tracings compatible with NRFHR. We compared the following variables: rate of cesarean delivery, indications for operative delivery due to NRFHR, and repercussions on the newborn’s acid-base status.

RESULTS:
The two groups differed significantly in the mode of delivery, with a cesarean delivery rate of 47.6% in group 1 vs. 30% in group 2 (p=0.032). The groups did not differ in the indications for ending labor due to NRFHR (62% vs. 61%, NS). In terms of neonatal outcomes, the 1-min Apgar score was 6 or lower in 17.8% of the group 1 neonates vs. 4.44% of the group 2 neonates (p<0.001). The groups also differed significantly in umbilical cord vein pH (7.23 vs. 7.27) and pCO2 (57.27 vs. 46.86) at birth.

CONCLUSIONS:
Fetal electrocardiography with the STAN® 21 system was more effective in detecting good fetal status and thus in identifying cases in which labor could proceed safely. Intrapartum surveillance with the STAN® 21 system reduced the rate of emergency cesarean delivery.

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 seven 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.

KUST based its decision on a recently published report from the Method Council for the Stockholm County Council – Region Gotland, “Fetal monitoring with computerized ST analysis during labor – a systematic review” (Report 2011:3).

The Method Council does not say that the Neoventa method is in any way inexpedient; however, they argue that there is not enough evidence that the method has scientifically proven benefits compared to other methods, with the exception of a reduced need for scalp blood sample during labor.

The Council has not taken all relevant facts regarding the scientific studies performed on STAN into consideration. The conclusion led to an incorrect basis for their decision. Neoventa is questioning why the Method Council decided to exclude important studies from their review – studies that show good results with the STAN method.

This method is currently used with great success in a majority of Swedish hospitals and in 80 to 90 percent of labor and delivery clinics in Norway, Belgium, and Denmark. It also has a high usage in several other countries in Europe and throughout the world. Neoventa can not accept that this method has been rejected by a group within the Stockholm County Council. Neoventa has therefore immediately initiated efforts to explore how the decision in Stockholm can be repealed so that a new more accurate evaluation can be performed.

We understand that the decision in Stockholm raises questions about the STAN-method and its value. STAN is not only the technology of ST Analysis, but also a comprehensive solution for improved obstetric care, which is used successfully in over 500 clinics worldwide today. Neoventa hopes that all existing and future users of the method will draw their own conclusions from experience and from all available research performed on the STAN- method.

Please feel free to contact us at Neoventa if you have questions.

Anders Due-Boje
CEO
+46 31 758 32 01
anders.due-boje@neoventa.com