Measurement of Fetal Blood LactateNCT02522273
Evaluation of the 'SensPoint' Lactate Meter in the Estimation of Foetal Scalp Blood and Umbilical Cord Blood Lactate
An observational study of Measurement of Fetal Blood Lactate, run by North Bristol NHS Trust at 1 site in United Kingdom.
Trial summary
A cardiotocograph (CTG) can be used in labour to assess the heartbeat and well-being of a baby. An abnormal CTG may be a sign that a baby has low oxygen levels (hypoxia) and is becoming distressed. In this situation a blood test can be taken from the scalp of the baby. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Measurement of Fetal Blood Lactate
- What is being tested?
- EKF Diagnostics 'SensPoint' Lactate Meter
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Mar 2016
- Phase
- Observational
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who have a fetal blood sample or umbilical cord blood sample taken for the measurement of lactate as part of their care during childbirth.
Who may be able to join
- women who have a fetal blood sample or umbilical cord blood sampling as part of their care during childbirth
Who cannot join
- women in Prison
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the 'SensPoint' Lactate Meter Validation of a Hand-Held Lactate Measuring System 'SensPoint' in the Estimation of Foetal Scalp Blood and Umbilical Cord Blood Lactate
A cardiotocograph (CTG) can be used in labour to assess the heartbeat and well-being of a baby. An abnormal CTG may be a sign that a baby has low oxygen levels (hypoxia) and is becoming distressed.
In this situation a blood test can be taken from the scalp of the baby. A high lactate level in the blood indicates that urgent delivery is required to prevent long-term harm to the newborn.
Read more
SensPoint is a new medical device that measures lactate. It has several potential benefits over the current method of measuring lactate in that it is a portable hand-held device (allowing for use in the delivery room), requires a much smaller volume of blood and produces results more quickly than the current method of measuring lactate.
Before a new device is adopted into clinical practice, it is important that it is first confirmed that it is accurate and reliable for its intended use. This study will evaluate the ability of the SensPoint device to accurately and reliably detect lactate in fetal and umbilical cord blood by comparing its performance to the reference device currently in use.
Read the detailed description
A cardiotocograph (CTG) can be used in labour to assess the heartbeat and well-being of a baby. An abnormal CTG may be a sign that a baby has low oxygen levels (hypoxia) and is becoming distressed.
In this situation a blood test can be taken from the scalp of the baby. A high lactate level or high acidity (low pH) in the blood indicates that urgent delivery is required to prevent long-term harm to the newborn.
Obtaining scalp blood can be difficult, time consuming and has a high failure rate. In the UK the majority of maternity units (including at North Bristol NHS Trust) will use a blood gas analyser to measure lactate. These are generally large, non-transportable devices located in or nearby the maternity unit. The blood gas analyser requires relatively large drops of baby's blood and due to it's fixed location, requires the midwife to leave the delivery room to process. Samples that are too small or contain air bubbles and blood clots will be rejected and need repeating. The process can take up to twenty minutes to complete.
After delivery blood from the umbilical cord is routinely obtained in high-risk deliveries for the measurement of pH and lactate. This establishes the wellbeing of the baby at the time of birth and can guide on-going treatment. Lactate in these samples is also measured using the blood gas analyser.
SensPoint is a new medical device that measures lactate. It has several potential benefits over the current method of measuring lactate in that it is a portable hand-held device (allowing for use in the delivery room), requires a much smaller volume of blood and produces results more quickly than the current method of measuring lactate.
Before a new device is adopted into clinical practice, it is important that it is first confirmed that it is accurate and reliable for its intended use. The researchers propose a study that will evaluate the ability of the SensPoint device to accurately and reliably detect lactate in both the laboratory and clinical setting by comparing its performance to the reference device currently in use.
The study will be divided into three parts:
- Comparison of the SensPoint device and the reference device in laboratory prepared samples.
- Comparison of the SensPoint device and the reference device using small volumes of leftover blood from umbilical cord blood testing obtained during routine care.
- Comparison of the SensPoint device and the reference device using small volumes of leftover blood from foetal scalp sampling obtained during routine care.
All foetal blood samples utilised in this study are surplus to clinical requirements and would otherwise be discarded. Retrospective consent will be obtained.
For the purposes of ensuring validity, reliability and repeatability of the device the researchers will test 90 laboratory standard samples, 90 arterial and venous cord blood samples and 90 foetal scalp capillary blood samples.
This study will enable the research team to design a larger study directly comparing the two methods of measuring lactate, assessing factors such as speed and patient satisfaction.
- Conditions
- Measurement of Fetal Blood Lactate
- Being tested
- EKF Diagnostics 'SensPoint' Lactate Meter
- Keywords
- Obstetric, Midwifery, Fetal blood sample, Lactate, Handheld meter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EKF Diagnostics 'SensPoint' Lactate MeterDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of lactate level in blood obtained from the fetal scalp measured using a Senspoint handheld lactate meter and the current gold standard.
Foetal blood sampling will be undertaken as clinically indicated by National Intrapartum Guidance and serum lactate will be measured in the usual manner using the current gold standard.
Once the serum lactate has been measured using the current gold standard (and the sample are no longer clinically useful and would normally be discarded) any blood remaining in the capillary tube will be handed to the research team. A member of the research team will then process the sample using the new Senspoint device.
Lactate readings from (i) the reference machine and (ii) the Senspoint device will be compared using a Bland-Altman plot, a difference plot used in analytical chemistry and biostatistics to analyze the agreement between two different assays.
Measured: Within 5 minutes of obtaining blood sample
Comparison of lactate level in blood obtained from the umbilical artery measured using a Senspoint handheld lactate meter and the current gold standard.
Blood from the umbilical artery will be sampled as clinically indicated by National Intrapartum Guidance and serum lactate will be measured in the usual manner using the current gold standard.
Once the serum lactate has been measured using the current gold standard (and the sample are no longer clinically useful and would normally be discarded) any blood remaining in the syringe will be handed to the research team. A member of the research team will then process the sample using the new Senspoint device.
Lactate readings from (i) the reference machine and (ii) the Senspoint device will be compared using a Bland-Altman plot, a difference plot used in analytical chemistry and biostatistics to analyze the agreement between two different assays.
Measured: Within 5 minutes of obtaining blood sample
Comparison of lactate level in blood obtained from the umbilical vein measured using a Senspoint handheld lactate meter and the current gold standard.
Blood from the umbilical vein will be sampled as clinically indicated by National Intrapartum Guidance and serum lactate will be measured in the usual manner using the current gold standard.
Once the serum lactate has been measured using the current gold standard (and the sample are no longer clinically useful and would normally be discarded) any blood remaining in the syringe will be handed to the research team. A member of the research team will then process the sample using the new Senspoint device.
Lactate readings from (i) the reference machine and (ii) the Senspoint device will be compared using a Bland-Altman plot, a difference plot used in analytical chemistry and biostatistics to analyze the agreement between two different assays.
Measured: Within 5 minutes of obtaining blood sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Measurement of Fetal Blood LactateStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Bristol NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- EKF Diagnostics
- Responsible party
- Principal investigator, Jo Crofts, North Bristol NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522273
- Sponsor's protocol ID
- 3493
- Status last verified
- Sep 2020
- First submitted
- 10 Aug 2015
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the 'SensPoint' Lactate Meter Validation of a Hand-Held Lactate Measuring System 'SensPoint' in the Estimation of Foetal Scalp Blood and Umbilical Cord Blood Lactate
- ClinicalTrials.gov ID
- NCT02522273
- Acronym / sponsor ID
- 3493
- Conditions
- Measurement of Fetal Blood Lactate
- Keywords
- Obstetric, Midwifery, Fetal blood sample, Lactate, Handheld meter
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- North Bristol NHS TrustUniversity, hospital or other
- Collaborators
- EKF Diagnostics
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (estimated)
- First posted
- 13 Aug 2015 (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.
A cardiotocograph (CTG) can be used in labour to assess the heartbeat and well-being of a baby. An abnormal CTG may be a sign that a baby has low oxygen levels (hypoxia) and is becoming distressed.
In this situation a blood test can be taken from the scalp of the baby. A high lactate level in the blood indicates that urgent delivery is required to prevent long-term harm to the newborn.
SensPoint is a new medical device that measures lactate. It has several potential benefits over the current method of measuring lactate in that it is a portable hand-held device (allowing for use in the delivery room), requires a much smaller volume of blood and produces results more quickly than the current method of measuring lactate.
Before a new device is adopted into clinical practice, it is important that it is first confirmed that it is accurate and reliable for its intended use. This study will evaluate the ability of the SensPoint device to accurately and reliably detect lactate in fetal and umbilical cord blood by comparing its performance to the reference device currently in use.
Detailed description
A cardiotocograph (CTG) can be used in labour to assess the heartbeat and well-being of a baby. An abnormal CTG may be a sign that a baby has low oxygen levels (hypoxia) and is becoming distressed.
In this situation a blood test can be taken from the scalp of the baby. A high lactate level or high acidity (low pH) in the blood indicates that urgent delivery is required to prevent long-term harm to the newborn.
Obtaining scalp blood can be difficult, time consuming and has a high failure rate. In the UK the majority of maternity units (including at North Bristol NHS Trust) will use a blood gas analyser to measure lactate. These are generally large, non-transportable devices located in or nearby the maternity unit. The blood gas analyser requires relatively large drops of baby's blood and due to it's fixed location, requires the midwife to leave the delivery room to process. Samples that are too small or contain air bubbles and blood clots will be rejected and need repeating. The process can take up to twenty minutes to complete.
After delivery blood from the umbilical cord is routinely obtained in high-risk deliveries for the measurement of pH and lactate. This establishes the wellbeing of the baby at the time of birth and can guide on-going treatment. Lactate in these samples is also measured using the blood gas analyser.
SensPoint is a new medical device that measures lactate. It has several potential benefits over the current method of measuring lactate in that it is a portable hand-held device (allowing for use in the delivery room), requires a much smaller volume of blood and produces results more quickly than the current method of measuring lactate.
Before a new device is adopted into clinical practice, it is important that it is first confirmed that it is accurate and reliable for its intended use. The researchers propose a study that will evaluate the ability of the SensPoint device to accurately and reliably detect lactate in both the laboratory and clinical setting by comparing its performance to the reference device currently in use.
The study will be divided into three parts:
- Comparison of the SensPoint device and the reference device in laboratory prepared samples.
- Comparison of the SensPoint device and the reference device using small volumes of leftover blood from umbilical cord blood testing obtained during routine care.
- Comparison of the SensPoint device and the reference device using small volumes of leftover blood from foetal scalp sampling obtained during routine care.
All foetal blood samples utilised in this study are surplus to clinical requirements and would otherwise be discarded. Retrospective consent will be obtained.
For the purposes of ensuring validity, reliability and repeatability of the device the researchers will test 90 laboratory standard samples, 90 arterial and venous cord blood samples and 90 foetal scalp capillary blood samples.
This study will enable the research team to design a larger study directly comparing the two methods of measuring lactate, assessing factors such as speed and patient satisfaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who have a fetal blood sample or umbilical cord blood sample taken for the measurement of lactate as part of their care during childbirth.
Key inclusion criteria (1 listed)
- women who have a fetal blood sample or umbilical cord blood sampling as part of their care during childbirth
Key exclusion criteria (1 listed)
- women in Prison
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 |
|---|---|---|
| EKF Diagnostics 'SensPoint' Lactate Meter | Device | – |
Primary outcome
Comparison of lactate level in blood obtained from the fetal scalp measured using a Senspoint handheld lactate meter and the current gold standard.
Time frame: Within 5 minutes of obtaining blood sample
Foetal blood sampling will be undertaken as clinically indicated by National Intrapartum Guidance and serum lactate will be measured in the usual manner using the current gold standard. Once the serum lactate has been measured using the current gold standard (and the sample are no longer clinically useful and would normally be discarded) any blood remaining in the capillary tube will be handed to the research team. A member of the research team will then process the sample using the new Senspoint device. Lactate readings from (i) the reference machine and (ii) the Senspoint device will be compared using a Bland-Altman plot, a difference plot used in analytical chemistry and biostatistics to analyze the agreement between two different assays.
Comparison of lactate level in blood obtained from the umbilical artery measured using a Senspoint handheld lactate meter and the current gold standard.
Time frame: Within 5 minutes of obtaining blood sample
Blood from the umbilical artery will be sampled as clinically indicated by National Intrapartum Guidance and serum lactate will be measured in the usual manner using the current gold standard. Once the serum lactate has been measured using the current gold standard (and the sample are no longer clinically useful and would normally be discarded) any blood remaining in the syringe will be handed to the research team. A member of the research team will then process the sample using the new Senspoint device. Lactate readings from (i) the reference machine and (ii) the Senspoint device will be compared using a Bland-Altman plot, a difference plot used in analytical chemistry and biostatistics to analyze the agreement between two different assays.
Comparison of lactate level in blood obtained from the umbilical vein measured using a Senspoint handheld lactate meter and the current gold standard.
Time frame: Within 5 minutes of obtaining blood sample
Blood from the umbilical vein will be sampled as clinically indicated by National Intrapartum Guidance and serum lactate will be measured in the usual manner using the current gold standard. Once the serum lactate has been measured using the current gold standard (and the sample are no longer clinically useful and would normally be discarded) any blood remaining in the syringe will be handed to the research team. A member of the research team will then process the sample using the new Senspoint device. Lactate readings from (i) the reference machine and (ii) the Senspoint device will be compared using a Bland-Altman plot, a difference plot used in analytical chemistry and biostatistics to analyze the agreement between two different assays.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Measurement of Fetal Blood Lactate, run by North Bristol NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 14 Sep 2020. 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 United Kingdom. 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 withdrawn before enrolling participants, so there are no results.
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?
Comparison of lactate level in blood obtained from the fetal scalp measured using a Senspoint handheld lactate meter and the current gold standard. (time frame: Within 5 minutes of obtaining blood sample). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2020.