Projectdetails

of


Continuous fetal lactate measurement – a game-changer in fetal monitoring

Keywords:
Neonatal outcome Fetal monitoring Lactate sensor

Researchers:
Dr. H. Groen
Prof. dr. P.P. van den Berg

Nature of the research:
Development, application and validation of a novel micro-dialysis probe allowing continuous intrapartum measurement of fetal metabolites such as lactate.

Fields of study:
biomaterials epidemiology obstetrics

Background / introduction
Fetal monitoring during labour is generally performed by electronic fetal heart rate monitoring. (EFM). Normal tracings indicate that the fetus is well oxygenated. In nearly half of all tracings, however, the results are not reassuring but only a small proportion of these fetuses are actually hypoxic. Since the introduction of EFM cesarean delivery rates have risen dramatically from 5 to 35% and higher, but there is no evidence that EFM has reduced the rate of hypoxia-induced neonatal encephalopathy. A better method to determine fetal hypoxia is needed to prevent unnecessary obstetric interventions.
A new method for fetal monitoring has been developed in the UMCG. The method uses microdialysis, pumping a small volume of fluid through a subcutaneous needle which can be inserted in the scalp of the fetus. The microdialysis has been patented as a needle integrated into the device already used for EFM. The microdialysis probe allows continuous measurement of lactate, giving optimal insight into the condition of the fetus and providing obstetricians with the best possible information to determine whether an intervention is necessary because of fetal distress.
A proof of principle study in oxygen-deprived animals and a study in healthy volunteers during exercise have been performed successfully. The development of the prototype into a system that allows real-time lactate levels to be read on a display is done in collaboration with M-dialysis in Sweden. The next step in the development of the method will be to repeat animal testing with the revised prototype and measurement system, which will be done in Sweden or Finland. The next stage will be to perform a pilot feasibility study in women during delivery. This study will also probably be performed in Sweden. Finally, a large multi-center randomized study will be performed to gather robust evidence of the effectiveness of the lactate probe.
Research question / problem definition
The following aspects of the probe will be studied:
1 Can the adapted prototype accurately and continuously measure lactate levels in an animal model with oxygen deprivation?
2 Can the microdialysis probe be used in the human situation to measure fetal lactate levels? Can the probe be placed in a reliable manner? Are the measurements accurate compared to fetal blood sampling? Are the measurements influenced by maternal fatigue and acidosis?
3 What is the effect of application of continuous fetal lactate monitoring on pregnancy outcomes compared to current practice? Does it result in fewer interventions and better neonatal outcomes?
Workplan
The project will start as soon as possible.
1 Collect the data from the animal study, scheduled for April/May 2019, analyse the data and write a paper (stage wetenschap, application for MD/PhD).
2 Prepare the study protocol and perform the pilot study in pregnant women with blinded application of continuous lactate monitoring during delivery. Data analysis and writing of a scientific paper.
3. Prepare the protocol for the randomized trial (publish the protocol). Coordinate the trial, collect the data and analyse the results. Write a paper about the study.
References
1. Belfort MA, Saade GR, Thom E, Blackwell SC, Reddy UM, Thorp JM,Jr, et al. A Randomized Trial of Intrapartum Fetal ECG ST-Segment Analysis. N Engl J Med. 2015 Aug 13;373(7):632-41.
2. Liljestrom L, Wikstrom AK, Hanson U, Akerud H, Jonsson M. Evaluation of the discrepancy between pH and lactate in combined fetal scalp blood sampling. Acta Obstet Gynecol Scand. 2011 Oct;90(10):1088-93.
3. Pyne DB, Boston T, Martin DT, Logan A. Evaluation of the Lactate Pro blood lactate analyser. Eur J Appl Physiol. 2000 May;82(1-2):112-6.
4. Wiberg-Itzel E, Lipponer C, Norman M, Herbst A, Prebensen D, Hansson A, et al. Determination of pH or lactate in fetal scalp blood in management of intrapartum fetal distress: randomised controlled multicentre trial. BMJ. 2008 Jun 7;336(7656):1284-7.
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Laatst gewijzigd: 23 februari 2012