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Australian and New Zealand Journal of Obstetrics and Gynaecology 2013; 53: 375380

DOI: 10.1111/ajo.12081

Original Article

Lactate study using umbilical cord blood: Agreement between Lactate


Pro hand-held devices with blood gas analyser and evaluation of lactate
stability over time
Tina Y. SU, Mifanwy REECE and Seng C. CHUA
Obstetrics and Gynaecology, Westmead Hospital, Sydney, New South Wales, Australia

Background: Lactate measurements have become increasingly preferred over pH analysis in the evaluation of fetal
acidaemia in labour. In a busy labour ward, often the umbilical cord may be sampled late and as a result yield unreliable
lactate values.
Aim: To investigate the agreement of hand-held device Lactate Pro with a reference method blood gas analyser and
evaluate the stability of umbilical cord lactate values over time.
Methods: Prospective study carried out at elective caesarean section. Sixteen umbilical cords were double clamped
immediately after delivery with paired arterial and venous blood samples collected by an independent researcher, at
varying time intervals, and processed by two Lactate Pro devices and a reference method blood gas analyser.
Results: A signicant difference of 0.41 to 0.10 mmol/L was found when different groups of Lactate Pro devices were
compared with blood gas analyser at lactate values up to 5.70 mmol/L, with average lactate value of 2.45 mmol/L. Over
time, there is progressive rise in lactate samples obtained from the umbilical cord.
Conclusion: Lactate Pro devices have a signicant difference, but when used in clinical practice on cord blood after
delivery, this is unlikely to be meaningful. In intrapartum fetal surveillance, a systematic overestimation might lead to
unnecessary intervention. It is possible to retrospectively predict the likely level of lactate at birth in delayed cord samples.
Key words: agreement, blood gas analyser, comparison, lactate, umbilical cord blood.

Introduction
Fetal lactate analysis is increasingly being used as a tool to
detect metabolic acidaemia and the decision for urgent
delivery in the presence of a nonreassuring cardiotocogram
(CTG) in birth units worldwide. Lactate values have been
found to correlate with, and are comparable to, fetal pH,
base decit and perinatal outcome.1 It has also been shown
that fetal lactate has better predictive value than pH for Apgar
score <4 at ve minutes as well as in relation to moderateto-severe hypoxicischaemic encephalopathy in scalp
samples.2 In addition, pH analysis has been demonstrated
to be associated with more intrapartum sampling failure
(1120%) compared with lactate analysis.3,4 As a result,
lactate measurements have become an attractive alternative

Correspondence: Dr Tina Su, Obstetrics and Gynaecology,


Westmead Hospital, Sydney, NSW, Australia. Email:
drtinasu@gmail.com
Conict of interest: None of the authors have a conict of
interest.
Received 10 July 2012; accepted 16 February 2013.

to the traditional pH assessment via fetal blood sampling


used since 1962.57
Hand-held lactate analysers have the advantages of ease
of use, shorter time to result and lower cost compared
with blood gas analysers, which commonly require a larger
sample of blood (up to 75 lL) as well as a processing
time up to 30 minutes.1,4,811 This includes the Accusport
meter which has been determined by Pennell et al.12 to
correlate well with a blood gas analyser, in addition to
being cheaper and more portable. One of the most
commonly used devices is the Lactate Pro (Arkray, KDK,
Kyoto, Japan), which has better correlation in tests dealing
with fetal blood concentrations in comparison with the
Accusport lactate analyser.13
An earlier study sponsored by the Lactate Pro
manufacturer had concluded that there was a strong
correlation between the Lactate Pro and existing blood gas
analysers up to 18 mmol/L.14 So far, a small number of
studies have investigated the correlation between lactate
measurements from this hand-held device with blood gas
analysers using fetal blood.8,13,15
In addition, current literature available shows conicting
results on the change of pH and lactate over time when
cord blood is not sampled immediately at birth. This
includes varying outcomes on the reliability of the pH or

2013 The Authors


ANZJOG 2013 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists
The Australian and
New Zealand Journal
of Obstetrics and
Gynaecology

375

T. Y. Su et al.

lactate values, when evaluated at different time intervals


after birth at different temperatures as well as in various
storage media.1622
In the rst part of the study, lactate values were
obtained using Lactate Pro devices and compared with
those obtained simultaneously with a reference method
blood gas analyser. This allowed comparison of Lactate
Pro performance with results obtained from other
preceding studies. In the second part of the study, lactate
values were measured up to 60 minutes after delivery.
The rate of change in lactate levels over time in umbilical
cord samples was then compared with syringe samples,
which has previously been shown to remain stable for up
to 30 minutes after delivery.19

Materials and Methods


A prospective study was carried out between June and
November 2008 in Westmead Hospital, Sydney, Australia.
Westmead Hospital has a tertiary-level obstetric unit
where over 5000 deliveries take place annually. Sixteen
umbilical cords were collected at elective caesarean
sections in low-risk women after 37 weeks of gestation,
following informed consent.

Protocol
Each umbilical cord was double clamped for the longest
length available immediately after delivery, placed in a
kidney dish and passed to the independent researcher for
sampling of all cords. Outside the operating room,
arterial samples were obtained rst followed by venous
samples using 23 gauge needles into prelabelled
preheparinised syringes kept on ice to be used as
control and then analysed at 5 to 20-minute intervals
up to 60 minutes. At the same time, umbilical cord
arterial and venous samples were collected via 23 gauge
needles, and also analysed at 5 to 20-minute intervals to
60 minutes. The maximum number of samples able to
be obtained per umbilical cord was processed at time
intervals as quickly as allowable by the same blood gas
analyser and Lactate Pro device. The rst samples were
collected from within 1 to 10 minutes of birth.

Manual. The Lactate Pro devices were calibrated with the


calibration strip that accompanies each packet of 25 strips,
before starting the new pack.

Statistical analysis
Results were analysed by paired t-tests. Values are
presented as mean differences of the groups compared
and standard deviation (SD), with P-value of <0.05
considered signicant. BlandAltman graphs were plotted
with mean difference of the group on Y-axis against the
mean lactate value on X-axis. Linear mixed-effects model
with SPSS software was used in the second part of the
study with calculation of change from initial values over
time.
As this study conforms to the standards established by
the NHMRC23 for ethical quality review, ethics approval
was not sought.

Results
Part one: agreement study
A total number of 479 lactate values were obtained from
the Lactate Pro devices and blood gas analysers. However,
17 results were excluded as these samples were not
processed by a Lactate Pro device and a blood gas
analyser at the same time to allow valid comparison. This
left 462 lactate values or 231 paired values for analysis in
groups for comparison as listed in Table 1.
A summary of the comparison groups and their mean
differences with limits of agreement is presented in
Table 2.
From Table 2, it can be seen there is a mean difference
of 0.10 mmol/L between the two hand-held Lactate Pro
devices, with a mean lactate value of 2.53 mmol/L. There
is also a consistent difference in LPro1 and ABG1 of
0.41, which is also signicant, whereby the Lactate Pro
device has consistently lower values of lactate compared
with blood gas analyser 1. On the other hand, LPro1

Table 1 Groups of lactate analysers for comparison


Groups

Equipment

Two Lactate Pro hand-held devices (marked LPro1 and


LPro2) and two Radiometer ABL735 Blood Gas
Analysers were used, one located in the Neonatal Intensive
Care Unit (NICU; ABG1) while the other is within the
operating theatre (ABG2). The arterial and venous
samples were all analysed at one or the other of the blood
gas analysers to compare with a Lactate Pro device at the
same time running in parallel. Some samples were
processed by both Lactate Pro devices to allow checking
for interdevice differences.
Both blood gas analysers are calibrated daily and comply
with Quality Control measures as per Manufacturers
376

2
3
4
5
6

Devices compared

No. of samples

Lactate Pro device 1 with Lactate Pro


device 2 (LPro1 LPro2)
Lactate Pro device 1 with blood gas
analyser 1 (LPro1 ABG1)
Lactate Pro device 1 with blood gas
analyser 2 (LPro1 ABG2)
Lactate Pro device 2 with blood gas
analyser 1 (LPro2 ABG1)
Lactate Pro device 2 with blood gas
analyser 2 (LPro2 ABG2)
Lactate Pro device 1 with combined
blood gas analyser 1 + 2
(LPro1 ABG 1 + 2)

48
62
123
7
65
185

2013 The Authors


ANZJOG 2013 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists

Lactate study agreement and time effect

Table 2 Mean differences with limits of agreement of the lactate groups compared
Groups for
comparison
LPro1
LPro1
LPro1
LPro2
LPro2
LPro1

LPro2
ABG1
ABG2
ABG1
ABG2
ABG (1 + 2)

Mean difference
(mmol/L)
0.10
0.41
0.01
0.14
0.01
0.13

SD

P-value

0.26
0.26
0.34
0.20
0.25
0.37

48
62
123
7
65
185

0.010
<0.001
0.747
0.106
0.884
<0.001

when compared with combined samples of both blood gas


analysers shows only a mean difference of 0.13, which is
signicant, with mean lactate value of 2.51. The combined
analysis of ABG1 and ABG2 was carried out to address
the potential error related to ABG1 measuring higher
lactate values compared with LPro1. In turn, both handheld Lactate Pro devices were compared with blood gas
analyser 2 which showed minimal differences, but these
results were not signicant. LPro2 compared with ABG1
only had a small number of seven samples and was not
signicant and as such a BlandAltman plot for this group
was not generated.
Figure 1 demonstrates the level of agreement on Bland
Altman plots which show linear regression analysis (mean
difference with 2 SD) between the 2 analysers compared.
The Y-axis represents difference between lactate values of
the two devices compared for each sample, and the X-axis
represents the mean of the lactate values from the two
devices from the corresponding sample. The closer the
cluster is around the value of 0.00 on the Y-axis
(difference) the higher the level of agreement there is
between the two devices compared.

Part two: analysis of lactate over time


A total of 176 cord venous lactate values were compared
with 88 syringe venous lactate values, and 124 cord arterial
lactate values compared with 91 syringe arterial lactate
values. These are plotted on two graphs against time to
show change over time when samples are kept in syringe on
ice compared with room temperature in umbilical cord.
In Figure 2 increasing change of lactate over time is
clearly demonstrated in samples extracted from the
umbilical cord compared with samples kept in syringe,
with a greater rate of change seen in the arterial samples
over time. The signicant change in lactate value over
time is calculated from an estimate of the within sample
change in value per unit time based on the initial value.

Discussion
The Lactate Pro meter is a convenient and versatile tool
currently used by many institutions to assess fetal acidosis
in the presence of a nonreassuring intrapartum CTG.24 In
our study, we have compared the Lactate Pro hand-held
devices with a blood gas analyser (ABL735) to assess the

Limits of
agreement
0.42
0.93
0.67
0.54
0.50
0.87

0.62
0.11
0.69
0.26
0.50
0.61

Mean of the
groups

Mean lactate
(mmol/L)

SD

(LPro1,LPro2)
(LPro1,ABG1)
(LPro1,ABG2)
(LPro2,ABG1)
(LPro2,ABG2)
(LPro1, ABG1 + 2)

2.53
2.47
2.53
2.36
2.31
2.51

0.79
0.64
0.88
0.52
0.80
0.81

agreement of these point-of-care devices as well as their


accuracy using the blood gas analyser as reference
method. Up to lactate values of 5.70 mmol/L (arterial)
and 4.90 mmol/L (venous) in umbilical cord blood
obtained from low-risk elective caesarean deliveries, we
can conclude that there is acceptable agreement of lactate
values with a minimal difference of
0.41 mmol/L.
However, it has to be noted that this minimal difference
may be more prominent given the more narrow cut-off for
reassuring fetal status of 4.8 mmol/L used with Lactate
Pro, compared with the suggested level of 5.4 mmol/L
used when measured with an acid-base analyser.2,8,25
There are signicant differences at mean lactate reading of
2.312.53 mmol/L, but the differences are unlikely to be
clinically meaningful. This nding is similar to an earlier
study conducted with 120 samples which compared
Lactate Pro and Accusport to a reference method
colorimetric plasma lactate analyser, which found Lactate
Pro had better correlation with a similar mean difference
of 0.40 mmol/L to our study of 231 samples.8 Another
study involved 118 samples comparing Nova Lactate Plus
and Lactate Pro to a reference method, which found
Lactate Pro values to correlate well up to 6.0 mmol/L with
a mean bias of 0.3  0.4 mmol/L.8 At their full range of
lactate values up to 14.7 mmol/L, the mean bias was
0.5  0.7 mmol/L.8 It can be noted on the Bland
Altman plots, there appear to be greater differences at
progressively higher values of lactate. We were only able
to obtain few higher values from our series of low-risk
elective caesarean deliveries. A study by Kruger et al.26
demonstrated signicant correlation between fetal scalp
lactate within 60 minutes of delivery to umbilical cord
arterial and venous lactate. It is then possible that the
results of an umbilical cord study may apply to fetal scalp
analysis. As a result of this umbilical cord study, a further
study involving fetal scalp sampling from high-risk
deliveries is under way to investigate higher levels of
lactate at Westmead Hospital. This is evaluated with
clinical context and will include neonatal outcome to
reassess the threshold for immediate delivery if higher
readings of lactate prove unreliable.
The second part of the study has demonstrated a
progressive rise in lactate over time for samples that remain
in the umbilical cord compared with those extracted
immediately into a syringe and kept on ice. There was a
signicant increase of 0.03 mmol/L per minute over time

2013 The Authors


ANZJOG 2013 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists

377

T. Y. Su et al.

(a)

COMPARISON BETWEEN LACTATE PRO DEVICES 1 AND 2

(b)

COMPARISON BETWEEN LACTATE PRO DEVICE 1 AND BLOOD


GAS ANALYSER 1

(c)

(d)

COMPARISON BETWEEN LACTATE PRO DEVICE 2 AND


BLOOD GAS ANALYSER 2

(e)

COMPARISON BETWEEN LACTATE PRO DEVICE 1 AND


BOTH BLOOD GAS ANALYSERS COMBINED

COMPARISON BETWEEN LACTATE PRO DEVICE 1


AND BLOOD GAS ANALYSER 2

Figure 1 (a) The two Lactate Pro devices are compared with each other, with the differences of LPro1 to LPro2 plotted against the
mean lactate values of the two devices. Broad dashed line is the mean difference of 0.10 mmol/L, with ne dashed lines being limits of
agreement from 0.42 to 0.62. (b) Lactate Pro (LPro1) is compared with blood gas analyser (ABG1), with differences plotted against
mean lactate values. Broad dashed line is the mean difference of 0.41 mmol/L, with ne dashed lines being limits of agreement of 0.93
to 0.11. (c) Lactate Pro (LPro1) is compared with blood gas analyser (ABG2), with differences plotted again mean lactate values. Broad
dashed line is the mean difference of 0.01 mmol/L, with ne dashed lines being limits of agreement of 0.67 to 0.69. (d) Lactate Pro
(LPro2) is compared with blood gas analyser (ABG2), with differences plotted again mean lactate values. Broad dashed line is the mean
difference of 0.01 mmol/L, with ne dashed lines being limits of agreement of 0.50 to 0.50. (e) Lactate Pro (LPro1) is compared with
both blood gas analyser results combined (ABG1 + 2), with differences plotted against mean lactate values. Broad dashed line is the mean
difference of 0.13 mmol/L, with ne dashed lines being limits of agreement of 0.87 to 0.61.

378

2013 The Authors


ANZJOG 2013 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists

Lactate study agreement and time effect

(a) VENOUS LACTATE VALUES (mmol/L) OVER TIME OBTAINED


FROM SYRINGE VERSUS UMBILICAL CORD
Type: Syringe

mmol/L

Type: Cord

10

20

30

40
50
Minutes

60

70

80

(b) ARTERIAL LACTATE VALUES (mmol/L) OVER TIME OBTAINED


FROM SYRINGE VERSUS UMBILICAL CORD
Type: Syringe

mmol/L

Type: Cord

10

20

30

40
50
Minutes

60

70

80

Figure 2 (a) showing stable venous lactate values obtained from


syringe samples compared with denite increasing values over
time from samples kept in umbilical cord. (b) showing stable
arterial lactate values obtained from syringe samples compared
with even more marked increasing values over time from samples
kept in umbilical cord.

in venous samples and an even higher increase of


0.05 mmol/L per minute in arterial samples. The rise in
lactate values over time may be due to the ongoing
metabolism of cord blood or vessel endothelium and is
supported by two other studies.18,20 The higher difference
in arterial samples is likely an effect from the more
lactacidemic nature of arterial cord blood, but could also
reect the greater metabolic activity in the arterial vessel
wall.20 These ndings are similar to the rate of change
derived by White et al.20 being 0.037 mmol/minute for
30 minutes and Dessolle et al.18 with 0.062 mmol/minute
in umbilical cord samples at room temperature. This has
clinical implications as often cord gases are not collected
immediately into a syringe at time of birth due to the need
to assist in neonatal resuscitation of a compromised
newborn. Hence, delayed analysis of umbilical cord blood
can lead to falsely high lactate readings being obtained,

which can have signicant medico-legal implications. The


falsely high lactate level may portray the neonate to be in
poorer condition than its actual state or lead to
misdiagnosis of hypoxicischaemic encephalopathy.18 In
any litigation case, the arterial lactate level can be
interpreted as vital evidence. From our study, we have
calculated the absolute change per minute of arterial and
venous blood lactate levels separately over time in room
air. This can be considered to predict the more likely
baseline lactate level at birth, when there has been delayed
cord blood collection. For example, an estimate of lactate
value at birth can be made by subtracting 0.05 multiplied by
x minutes since delivery from the delayed arterial lactate
value obtained. Similarly, estimation of venous lactate value
can be made by subtracting 0.03 multiplied by x minutes
since delivery from the delayed lactate value. However, it
must be used with caution as our algorithm reects our
specic group of low-risk deliveries only, where further
studies involving large sample and diverse obstetric range
are required for more meaningful extrapolation.
One of the strengths of our study includes having one
independent researcher for collection of all samples to
ensure consistency and reliable technique. Collections of
repetitive samples from the same umbilical cord also allow
more reliable comparison with change over time. The
limitations of our study include a small sample size of 16
umbilical cords obtained from low-risk clinical situations.
This allowed us to analyse only the normal range of
lactate values up to 5.7 mmol/L. Further studies are
needed to evaluate the change in lactate at higher readings
with a greater sample size. Also, the reference method
blood gas analyser (ABG1) is located in NICU which
contributed to the longer time delay (up to 10 minutes
from delivery) taken to process the rst samples of each
cord with this blood gas analyser. However, the samples
were able to be processed simultaneously by the Lactate
Pro device and a reference method blood gas analyser to
allow for agreement part of the study. The consistent
overestimation by ABG1 when compared with LPro1 may
reect a likely systematic difference attributable to the
blood gas analyser. This is because the two Lactate Pro
devices were compared with each other and showed a
similar result with a minimal difference of 0.10. Due to
time constraint of sample processing, syringe samples kept
on ice were not all able to be warmed prior to processing,
and this may have uncertain effect on the analysis. In
summary, when measuring umbilical cord blood, the
Lactate Pro hand-held device does not have clinically
signicant difference when compared with a reference
method blood gas analyser. Over time, there is a
progressive increase in lactate value from samples obtained
from blood remaining in the umbilical cord, with a greater
difference seen in arterial samples.

Acknowledgement
We wish to thank Karen Byth statistician at Westmead
Hospital for her invaluable contribution to our data analysis.

2013 The Authors


ANZJOG 2013 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists

379

T. Y. Su et al.

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2013 The Authors


ANZJOG 2013 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists

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