Evaluation of the 'SensPoint' Lactate Meter in the Estimation of Foetal Scalp Blood and Umbilical Cord Blood Lactate
1 other identifier
observational
N/A
1 country
1
Brief 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. 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.
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedSeptember 14, 2020
September 1, 2020
5 months
August 10, 2015
September 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Within 5 minutes of obtaining blood sample
Interventions
Eligibility Criteria
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.
You may qualify if:
- women who have a fetal blood sample or umbilical cord blood sampling as part of their care during childbirth
You may not qualify if:
- women in Prison
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- North Bristol NHS Trustlead
- EKF Diagnosticscollaborator
Study Sites (1)
North Bristol NHS Trust
Bristol, BS10 5NB, United Kingdom
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Joanna Crofts
Study Record Dates
First Submitted
August 10, 2015
First Posted
August 13, 2015
Study Start
October 1, 2015
Primary Completion
March 1, 2016
Last Updated
September 14, 2020
Record last verified: 2020-09