Evaluation of the Senspoint Lactate Meter
Research type
Research Study
Full title
Validation of a Hand Held Lactate Measuring System ‘Senspoint’ in the Estimation of Fetal Scalp Blood and Umbilical Cord Blood Lactate
IRAS ID
177487
Contact name
Joanna Crofts
Contact email
Sponsor organisation
EKF Diagnostic Holdings plc
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
A cardiotocograph (CTG) can be used in labour to assess the heartbeat and well-being of a baby. An abnormal CTG is sometimes a sign that a baby has low oxygen levels (hypoxia).
In this situation a blood test from the scalp of the baby can be performed. A high lactate level or high acidity (low pH) indicates that urgent delivery is required to prevent long-term harm to the newborn.
Obtaining scalp blood can be difficult and has a high failure rate. The machine that measures lactate demands large drops of baby’s blood and requires the midwife to leave the 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.
After a baby has been born blood from the umbilical cord is routinely obtained in high-risk cases for the measurement of pH and lactate. This establishes the oxygenation at birth and can guide on-going care.
Senspoint is a new handheld device that measures lactate. It is portable, allowing use in the delivery room, requires a much smaller volume of blood and produces results more quickly than the current method of measuring lactate.
The accuracy of Senspoint has yet to be confirmed in foetal blood. We propose a study that will evaluate the capacity of this device to detect lactate in different foetal blood samples.
Small volumes of leftover blood from foetal scalp and umbilical cord blood testing would be processed using the device to measure lactate. These samples are surplus to clinical requirements and would normally be discarded. We will then compare the results with the current method of measuring lactate to ascertain the accuracy of the new device.
This study will enable the research team to design a larger study comparing the two methods of measuring lactate.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0323
Date of REC Opinion
29 Oct 2015
REC opinion
Further Information Favourable Opinion