Metabolic Acidosis of NewbornNCT01699646
Cadiotocography Combined With ST-analysis Versus Cardiotocography Combined With Scalp-pH
A study testing Neoventa S 21 ST-ANalysis of fetal heart and CTG + FBS in people with Metabolic Acidosis of Newborn, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Hypothesis: STAN monitoring will reduce the number of interventions because of suspected fetal asphyxia and reduce the number of newborns with metabolic acidosis. Primary endpoint: 1) Frequency of metabolic acidosis in the two groups, defined by pH in umbilical cord artery < 7.05 and standard base excess <-10. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Metabolic Acidosis of Newborn
- What is being tested?
- Neoventa S 21 ST-ANalysis of fetal heart and CTG + FBS
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,025 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2005to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- intermediate or abnormal CTG and
- Normal fetal scalp-pH > or = 7,25
Who cannot join
- preterminal CTG
- Fetal arrythmias or A-V block
- Severe fetal malformations (known)
- Amnionitis (temp > 38,5 degr. celcius)
- maternal Hepatitis B/C or HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiotocography Combined With ST-analysis Versus Cardiotocography Combined With Scalp-pH in Deliveries With Abnormal CTG - A Randomised Trial
Hypothesis:
STAN monitoring will reduce the number of interventions because of suspected fetal asphyxia and reduce the number of newborns with metabolic acidosis.
Read more
Primary endpoint:
- Frequency of metabolic acidosis in the two groups, defined by pH in umbilical cord artery < 7.05 and standard base excess <-10.
Secondary endpoints:
- Number of intervention (VE and caesarean section) in the two groups
- Number of pH measurements in the two groups
- Number of neonates admitted to the neonatal department because of suspected asphyxia in the two groups
The aim of fetal surveillance is to identify those fetuses at risk for developing damage in newborn to term or long term damage caused by lack of oxygen during birth process. Approximately 1/10 of all cases of paralysis due to brain damage (cerebral palsy) is believed to be caused by lack of oxygen during birth. These can be avoided if the investigators intervene actively in the birth before damage occurs.
CardioTocoGraphy (CTG = detection of fetal heart rate pattern and maternal uterine contractions via electrodes on the maternal abdomen and fetal scalp) is a widely used method of fetal surveillance. However, it can be difficult to interpret a CTG, and uncertainty in CTG interpretation may therefore lead to increase in the number of deliveries with vacuum suction and caesarean section. Interpretation of CTG can be improved by analyzing the acidity of a blood sample taken from the skin of the fetal scalp. Such a scalp pH analysis shows indirectly the fetus gets enough oxygen. Scalp pH measurement requires expertise and requires repeated measurements if the abnormal heart rate pattern persists. This method is the normal routine at the maternity ward at Hvidovre Hospital / Roskilde County Hospital.
The problem seems to be partially alleviated by using a newly developed method for fetal surveillance called STAN (ST analysis). By STAN continuously recorded both CTG and fetal ECG (electrocardiography = recording of the electrical heart activity). Simultaneously analyzes a portion of the fetal ECG, namely ST-part because hypoxia leads to changes in it. The technique is easy to use, since it only requires one electrode on the fetal scalp that is placed in the same way as in ordinary CTG registration.
Read the detailed description
The value of STAN (ST analysis) was assessed in 2 randomized trials and shows: 1) A reduction in the incidence of severe hypoxia in fetuses during labor and 2) A reduction in frequency of redemption with suction and caesarean section due to lack of oxygen during the birth process.
Within the last year however, there is substantial new information regarding. STAN. The Swedish Social Board has published a newsletter (17) which describes a possible risk of birth of asphyxiated children, some died and others have cerebral palsy. A new Finnish study (18) suggests that there may be an increased risk of (moderate) acidosis after using STAN.
The above has led to considerable debate, not just in Sweden but also throughout Europe. This has led to the Swedish, Danish (Newsletter 1, Annex 1b) and the common Nordic reference group for STAN orally has announced new clinical guidelines for STAN application. A recently held workshop in Utrecht, Holland will generate joint European guideline, these will be sought published. Against this background it has been necessary to develop new guidelines for the complement of scalp pH in the STAN arm of this project (Annex 1a)
Common to the above studies is that there is consistently applied scalp pH before STAN monitoring begins. It is therefore important to elucidate whether, through the use of STAN monitoring is needed (more than 1) FBS - and if so to what extent FBS is required.
STAN method currently winning widespread in Denmark and internationally (FDA has just approved), notwithstanding that it is not scientifically proven that fetal monitoring with STAN is better than the current monitoring method with scalp pH measurement. It is therefore important to get this resolved in a randomized study in the relative expensive STAN apparatus introduced in several places in Denmark.
This study will provide an opportunity to highlight these issues and can prepare on our way to use STAN to prevent or significantly reduce these risks and thus justify continued STAN use or the continued spread of STAN should not by advised.
If STAN by our method proves to be comparable with clean scalps pH measurement as an adjunct to CTG, it will be a significant advance in fetal monitoring technology, taking thus will have a primarily non-invasive, safe and continuous method cause less inconvenience to both mother and child.
The study was approved by the Ethical nominee directors.
The study will include all women > 18 years in labour with a fetus in the cephalic presentation with a gestational age of more than 36 weeks + 0, where there is the monitoring with CTG.
Women who develop CTG changes that are interpreted as abnormal (according to STAN (FIGO)-guidelines and the scalp pH is normal, could be included in the study. Women will be randomised by telephone(electronic)to surveillance with eighter STAN monitoring or with CTG and scalp pH. In the latter group STAN results will be blinded (hidden) for later analysis.
There are estimated to be 1200 women in the study and the study is expected to run for 2-3 years, preceded by a pilotproject.
During the pilot project we will follow the department's usual procedures for monitoring, but to CTG using the STAN device with blinded/concealed ST analysis. There is expected to be 100 patients in the pilotproject. The aim is to investigate whether the calculations in the survey stick and simultaneously train staff at the maternity ward in STAN equipment and procedures and make them familiar with the work.
The advantage in conducting the study at the maternity ward at Hvidovre hospital is that it is the largest birthplace in Denmark with nearly 6,000 births annually, with perhaps the highest use of scalp pH measurements during labor. In addition, nearly 3,000 births annually at Roskilde County Hospital, a total of 9,500 births. In addition, department and project managers areexperienced in scientific studies on fetal monitoring.
Project participants have on their own initiative, initiated this project and has no financial interest in the instrument companies that produce the used equipment/ appliances/ monitors.
The project has been allocated 2.5 million DKr in funding for the project from Elsass Foundation, a private foundation with no financial interest in the project equipment/ appliances/ monitors.
- Conditions
- Metabolic Acidosis of Newborn
- Being tested
- Neoventa S 21 ST-ANalysis of fetal heart, CTG + FBS
- Keywords
- Intrapartum fetal surveillance, CTG, cardiotocography, STAN, ST-Analysis, metabolic acidosis in umbilical artery, operative delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoventa S 21 ST-ANalysis of fetal heartDevice
Also called Cardiotocography and ST-ANalysis
Application of "gold-trace" scalp electrode
CTG + FBSProcedure or surgery
Also called Cardiotocography and fetal blood sampling (scalp-pH)
Cardiotocography and fetal blood sampling on/from fetal skalp
| Study group | Role | What they receive |
|---|---|---|
| CTG + FBS | Active comparator | intrapartum surveillance with CTG+FBS Receives: Procedure: CTG + FBS |
| Neoventa S 21 ST-ANalysis of fetal heart | Active comparator | intrapartum surveillance with CTG + STAN Receives: Device: Neoventa S 21 ST-ANalysis of fetal heart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of metabolic acidosis in the 2 groups, defined by pH < 7,05 and SBE < -10 in the umbilical artery
We will do a minimum 2 year follow-up on the children
Measured: within 1 hour
Secondary outcomes (2)
Does STAN reduce number of admissions to NICU and/or HIE
Number of neonates admitted to NICU because of suspected asphyxia in the two groups. There will also be a minimun of 2 years of follow-up in these children
Measured: 2 years after termination of study
Does STAN reduce number of interventions in delivery(vacuum or section)
Measured: 1 year after termination of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startDec 2005
- Primary completionJan 2011
- Study completionDec 2012 (estimated)
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Acidosis of NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,025 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ElsassFonden
- Responsible party
- Principal investigator, Diana BB Bach, MD, Hvidovre University Hospital
- Investigators
- Niels J Secher, prof, MD, Study director, Copenhagen University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699646
- Sponsor's protocol ID
- CTG+ST vs CTG +scalp-pH, DK
- Status last verified
- Oct 2012
- First submitted
- 10 Jan 2012
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Victor SF, Bach DBB, Hvelplund AC, Nickelsen C, Lyndrup J, Wilken-Jensen C, Scharff LJ, Weber T, Secher NJ, Krebs L. Cardiotocography combined with ST analysis versus cardiotocography combined with fetal blood sampling in deliveries with abnormal CTG: a randomized trial. Arch Gynecol Obstet. 2023 Jun;307(6):1771-1780. doi: 10.1007/s00404-022-06649-3. Epub 2022 Jun 14.
PubMed 35701639
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiotocography Combined With ST-analysis Versus Cardiotocography Combined With Scalp-pH in Deliveries With Abnormal CTG - A Randomised Trial
- ClinicalTrials.gov ID
- NCT01699646
- Acronym / sponsor ID
- CTG+ST vs CTG +scalp-pH, DK
- Conditions
- Metabolic Acidosis of Newborn
- Keywords
- Intrapartum fetal surveillance, CTG, cardiotocography, STAN, ST-Analysis, metabolic acidosis in umbilical artery, operative delivery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 1,025 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- ElsassFonden
- Study start
- Dec 2005
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis:
STAN monitoring will reduce the number of interventions because of suspected fetal asphyxia and reduce the number of newborns with metabolic acidosis.
Primary endpoint:
- Frequency of metabolic acidosis in the two groups, defined by pH in umbilical cord artery < 7.05 and standard base excess <-10.
Secondary endpoints:
- Number of intervention (VE and caesarean section) in the two groups
- Number of pH measurements in the two groups
- Number of neonates admitted to the neonatal department because of suspected asphyxia in the two groups
The aim of fetal surveillance is to identify those fetuses at risk for developing damage in newborn to term or long term damage caused by lack of oxygen during birth process. Approximately 1/10 of all cases of paralysis due to brain damage (cerebral palsy) is believed to be caused by lack of oxygen during birth. These can be avoided if the investigators intervene actively in the birth before damage occurs.
CardioTocoGraphy (CTG = detection of fetal heart rate pattern and maternal uterine contractions via electrodes on the maternal abdomen and fetal scalp) is a widely used method of fetal surveillance. However, it can be difficult to interpret a CTG, and uncertainty in CTG interpretation may therefore lead to increase in the number of deliveries with vacuum suction and caesarean section. Interpretation of CTG can be improved by analyzing the acidity of a blood sample taken from the skin of the fetal scalp. Such a scalp pH analysis shows indirectly the fetus gets enough oxygen. Scalp pH measurement requires expertise and requires repeated measurements if the abnormal heart rate pattern persists. This method is the normal routine at the maternity ward at Hvidovre Hospital / Roskilde County Hospital.
The problem seems to be partially alleviated by using a newly developed method for fetal surveillance called STAN (ST analysis). By STAN continuously recorded both CTG and fetal ECG (electrocardiography = recording of the electrical heart activity). Simultaneously analyzes a portion of the fetal ECG, namely ST-part because hypoxia leads to changes in it. The technique is easy to use, since it only requires one electrode on the fetal scalp that is placed in the same way as in ordinary CTG registration.
Detailed description
The value of STAN (ST analysis) was assessed in 2 randomized trials and shows: 1) A reduction in the incidence of severe hypoxia in fetuses during labor and 2) A reduction in frequency of redemption with suction and caesarean section due to lack of oxygen during the birth process.
Within the last year however, there is substantial new information regarding. STAN. The Swedish Social Board has published a newsletter (17) which describes a possible risk of birth of asphyxiated children, some died and others have cerebral palsy. A new Finnish study (18) suggests that there may be an increased risk of (moderate) acidosis after using STAN.
The above has led to considerable debate, not just in Sweden but also throughout Europe. This has led to the Swedish, Danish (Newsletter 1, Annex 1b) and the common Nordic reference group for STAN orally has announced new clinical guidelines for STAN application. A recently held workshop in Utrecht, Holland will generate joint European guideline, these will be sought published. Against this background it has been necessary to develop new guidelines for the complement of scalp pH in the STAN arm of this project (Annex 1a)
Common to the above studies is that there is consistently applied scalp pH before STAN monitoring begins. It is therefore important to elucidate whether, through the use of STAN monitoring is needed (more than 1) FBS - and if so to what extent FBS is required.
STAN method currently winning widespread in Denmark and internationally (FDA has just approved), notwithstanding that it is not scientifically proven that fetal monitoring with STAN is better than the current monitoring method with scalp pH measurement. It is therefore important to get this resolved in a randomized study in the relative expensive STAN apparatus introduced in several places in Denmark.
This study will provide an opportunity to highlight these issues and can prepare on our way to use STAN to prevent or significantly reduce these risks and thus justify continued STAN use or the continued spread of STAN should not by advised.
If STAN by our method proves to be comparable with clean scalps pH measurement as an adjunct to CTG, it will be a significant advance in fetal monitoring technology, taking thus will have a primarily non-invasive, safe and continuous method cause less inconvenience to both mother and child.
The study was approved by the Ethical nominee directors.
The study will include all women > 18 years in labour with a fetus in the cephalic presentation with a gestational age of more than 36 weeks + 0, where there is the monitoring with CTG.
Women who develop CTG changes that are interpreted as abnormal (according to STAN (FIGO)-guidelines and the scalp pH is normal, could be included in the study. Women will be randomised by telephone(electronic)to surveillance with eighter STAN monitoring or with CTG and scalp pH. In the latter group STAN results will be blinded (hidden) for later analysis.
There are estimated to be 1200 women in the study and the study is expected to run for 2-3 years, preceded by a pilotproject.
During the pilot project we will follow the department's usual procedures for monitoring, but to CTG using the STAN device with blinded/concealed ST analysis. There is expected to be 100 patients in the pilotproject. The aim is to investigate whether the calculations in the survey stick and simultaneously train staff at the maternity ward in STAN equipment and procedures and make them familiar with the work.
The advantage in conducting the study at the maternity ward at Hvidovre hospital is that it is the largest birthplace in Denmark with nearly 6,000 births annually, with perhaps the highest use of scalp pH measurements during labor. In addition, nearly 3,000 births annually at Roskilde County Hospital, a total of 9,500 births. In addition, department and project managers areexperienced in scientific studies on fetal monitoring.
Project participants have on their own initiative, initiated this project and has no financial interest in the instrument companies that produce the used equipment/ appliances/ monitors.
The project has been allocated 2.5 million DKr in funding for the project from Elsass Foundation, a private foundation with no financial interest in the project equipment/ appliances/ monitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTG + FBS | Active comparator | Procedure: CTG + FBSintrapartum surveillance with CTG+FBS |
| Neoventa S 21 ST-ANalysis of fetal heart | Active comparator | Device: Neoventa S 21 ST-ANalysis of fetal heartintrapartum surveillance with CTG + STAN |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- intermediate or abnormal CTG and
- Normal fetal scalp-pH > or = 7,25
Key exclusion criteria (5 listed)
- preterminal CTG
- Fetal arrythmias or A-V block
- Severe fetal malformations (known)
- Amnionitis (temp > 38,5 degr. celcius)
- maternal Hepatitis B/C or HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoventa S 21 ST-ANalysis of fetal heartAlso: Cardiotocography and ST-ANalysisApplication of "gold-trace" scalp electrode | Device | Neoventa S 21 ST-ANalysis of fetal heart |
| CTG + FBSAlso: Cardiotocography and fetal blood sampling (scalp-pH)Cardiotocography and fetal blood sampling on/from fetal skalp | Procedure or surgery | CTG + FBS |
Primary outcome
Frequency of metabolic acidosis in the 2 groups, defined by pH < 7,05 and SBE < -10 in the umbilical artery
Time frame: within 1 hour
We will do a minimum 2 year follow-up on the children
2 secondary outcomes
Does STAN reduce number of admissions to NICU and/or HIE
Time frame: 2 years after termination of study
Does STAN reduce number of interventions in delivery(vacuum or section)
Time frame: 1 year after termination of study
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- Derived from this study: PubMed 35701639Victor SF, Bach DBB, Hvelplund AC, Nickelsen C, Lyndrup J, Wilken-Jensen C, Scharff LJ, Weber T, Secher NJ, Krebs L. Cardiotocography combined with ST analysis versus cardiotocography combined with fetal blood sampling in deliveries with abnormal CTG: a randomized trial. Arch Gynecol Obstet. 2023 Jun;307(6):1771-1780. doi: 10.1007/s00404-022-06649-3. Epub 2022 Jun 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels J Secher, prof, MD study director
Copenhagen University, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neoventa S 21 ST-ANalysis of fetal heart and CTG + FBS in people with Metabolic Acidosis of Newborn, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of metabolic acidosis in the 2 groups, defined by pH < 7,05 and SBE < -10 in the umbilical artery (time frame: within 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01699646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2012.