Measurement of Fetal Blood Lactate Clinical Trial
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
| NCT number | NCT02522273 |
| Other study ID # | 3493 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 2015 |
| Verified date | September 2020 |
| Source | North Bristol NHS Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - women who have a fetal blood sample or umbilical cord blood sampling as part of their care during childbirth Exclusion Criteria: - women in Prison |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | North Bristol NHS Trust | Bristol |
| Lead Sponsor | Collaborator |
|---|---|
| North Bristol NHS Trust | EKF Diagnostics |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 |