Clinical evaluation of Statstrip<sup>®</sup> Lactate for use in fetal scalp blood sampling

Heinis, Ayesha M F; Dillen, Jeroen van; Rhöse, Sarah; Vandenbussche, Frank P.H.A.; Drongelen, J. van

doi:10.1111/aogs.13078

Cited by 11 publications

(12 citation statements)

References 23 publications

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“…This is the first study to recommend cutoffs for fetal scalp lactate measured by a POC device to safely rule out hypoxia, with values correlated directly to different neonatal outcomes and predefined combinations of cord blood gases. 5,6,11,14,15 The optimal cutoff lactate value for MA was 5.7 mmol/l but as we aim to prevent rather than to diagnose MA, the suggested cutoff ≥5.2 mmol/l strikes a balance between obtaining the best sensitivity, specificity and negative likelihood ratio for the various neonatal outcomes. A higher cutoff value would result in too low sensitivity for 5 minute Apgar score <7 and for the composite outcome.…”

Section: Discussionmentioning

confidence: 99%

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Proposed cutoff for fetal scalp blood lactate in intrapartum fetal surveillance based on neonatal outcomes: a large prospective observational study

Iorizzo

Carlsson

Johansson

et al. 2021

BJOG

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Objective Determination of lactate in fetal scalp blood (FBS) during labour has been recognised since the 1970s. The internationally accepted cutoff of >4.8 mmol/l indicating fetal acidosis is exclusive for the point‐of‐care device (POC) LactatePro™, which is no longer in production. The aim of this study was to establish a new cutoff for scalp lactate based on neonatal outcomes with the use of the StatstripLactate®/StatstripXpress® Lactate system, the only POC designed for hospital use. Design Observational study. Setting January 2016 to March 2020 labouring women with indication for FBS were prospectively included from seven Swedish and one Australian delivery unit. Population Inclusion criteria: singleton pregnancy, vertex presentation, ≥35+0 weeks of gestation. Method Based on the optimal correlation between FBS lactate and cord pH/lactate, only cases with ≤25 minutes from FBS to delivery were included in the final calculations. Main outcome measures Metabolic acidosis in cord blood defined as pH <7.05 plus BDecf >10 mmol/l and/or lactate >10 mmol/l. Results A total of 3334 women were enrolled of whom 799 were delivered within 25 minutes. The areas under the receiver operating characteristics curves (AUC) and corresponding optimal cutoff values were as follows; metabolic acidosis AUC 0.87 (95% CI 0.77–0.97), cutoff 5.7 mmol/l; pH <7.0 AUC 0.83 (95% CI 0.68–0.97), cutoff 4.6 mmol/l; pH <7.05 plus BDecf ≥12 mmol/l AUC 0.97 (95% CI 0.92–1), cutoff 5.8 mmol/l; Apgar score <7 at 5 minutes AUC 0.74 (95% CI 0.63–0.86), cutoff 5.2 mmol/l; and pH <7.10 plus composite neonatal outcome AUC 0.76 (95% CI 0.67–0.85), cutoff 4.8 mmol/l. Conclusion A scalp lactate level <5.2 mmol/l using the StatstripLactate®/StatstripXpress® system will safely rule out fetal metabolic acidosis. Tweetable abstract Scalp blood lactate <5.2 mmol/l using the StatstripLactate®/StatstripXpress system has an excellent ability to rule out fetal acidosis.

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Section: Discussionmentioning

confidence: 99%

“…The performance and accuracy in fetal and adult blood for several POC‐lactate‐meters have been published 6,10,11 . SSLX has been shown to perform with good accuracy and agreement to the stationary blood gas machines 11–15 . It is important to recognise that lactate values vary depending on the POC‐lactate‐meter used 1,6 .…”

Section: Introductionmentioning

confidence: 99%

Proposed cutoff for fetal scalp blood lactate in intrapartum fetal surveillance based on neonatal outcomes: a large prospective observational study

Iorizzo

Carlsson

Johansson

et al. 2021

BJOG

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“…In addition, cut-off lactate values differ between different point-ofcare devices and every device has its own limits. In this study, we used a Statstrip 1 device, and a similar device was used by Reif et al and Heinis et al [10,13,14]. A strength of this study is its clinical nature, and data were collected in one tertiary university centre over a short time period.…”

Section: Discussionmentioning

confidence: 99%

Fetal lactate levels align with the stage of labour

Mönkkönen

Saarelainen

et al. 2021

European Journal of Obstetrics & Gynecology and Reproductiv

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To evaluate the association between lactate concentrations in fetal blood samples and the different advanced labour stages. Methods: Eighteen-month prospective population-based clinical study of 187 singleton pregnant women in labour who were monitored by fetal blood sampling (FBS) because of non-reassuring intrapartum CTG results at Kuopio University Hospital, Finland. Peripheral lactate concentration and pH were analysed at different stages of labour and in umbilical arterial samples immediately after delivery. Results: FBS samples (N = 350) were obtained from 5.4 % of all women in labour during the study period, and 48 % had spontaneous delivery, 27 % had vacuum-assisted vaginal delivery, and 25 % had nonelective Caesarean delivery. FBS lactate levels increased 4-11% with every 1-2 cm of cervical dilation and 18 % from early labour to fully dilated cervix. In 42 women with at least two FBSs, lactate levels increased significantly from the early I stage of labour and up to a fully dilated cervix. Lactate values were significantly higher in umbilical arterial samples compared to FBSs. Sensitivity of the highest FBS lactate values for the detection of birth asphyxia were considerably low varying between 42.9-57.1%. Conclusion: FBS lactate levels were related to the stage of labour during vaginal delivery attempt. Wide range of lactate levels during labour complicates its use as a predictor of birth asphyxia.

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“…They are equally calibrated but the StatstripLactate meter has the advantage of being able to transfer data in real time to an electronic medical record system. The performance and accuracy in fetal and adult blood for several POC lactate meters have been published, with SSLX performing with better accuracy and agreement to the stationary blood gas machines (6,(10)(11)(12)(13)(14). It is important to recognize that lactate values vary depending on the POC-lactate-meter used (1,6).…”

Section: Introductionmentioning

confidence: 99%

“…Various interventional cut-offs for SSLX have been suggested. However, all are based on a small number of participants and on conversion equations from the existing accepted cut-offs of LP or pH and not on neonatal outcome (12)(13)(14).…”

Section: Introductionmentioning

confidence: 99%

Proposed cut-off for fetal scalp blood lactate in intrapartum fetal surveillance based on neonatal outcomes: a prospective observational study

Iorizzo

Carlsson

Johansson

et al. 2021

Preprint

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Objective Determination of lactate in fetal scalp blood (FBS) during labor has been studied since the 1970s. The internationally accepted cut-off of >4.8mmol/L indicating fetal acidaemia is exclusive for the point-of-care device (POC) LactateProTM, which is no longer in production. The aim of this study was to present a new cut-off for scalp lactate based on neonatal outcomes with the use of StatstripLactate®/StatstripXpress® Lactate system, the only POC lactate meter designed for hospital use. Design Observational Study Setting January 2016 to March 2020 labouring women with an indication for FBS were prospectively included from seven Swedish and one Australian delivery unit. Population Inclusion criteria: singleton pregnancy, vertex presentation, ≥35+0 gestational weeks. Method Based on the optimal correlation between FBS lactate and cord pH/lactate, only cases with ≤25 minutes from FBS to delivery were included in the final calculations. Main outcome measures Metabolic acidosis in cord blood was defined as pH <7.05 plus BDecf >10 mmol/L and/or lactate >10 mmol/L. Results 3334 women were enrolled of which 799 were delivered within 25 minutes. The areas under the ROC curves (AUC) and corresponding optimal lactate cut-off values were as follows; metabolic acidosis AUC 0.87(95% CI:0.77-0.97), cut-off 5.7mmol/L; pH <7.0 AUC 0.83(95% CI:0.68-0.97), cut-off 4.6mmol/L; pH <7.05 plus BD ≥12mmol/L AUC 0.97(95% CI:0.92-1), cut-off 5.8mmol/L; Apgar score <7 at 5 minutes AUC 0.74(95% CI:0.63-0.86), cut-off 5.2mmol/L; and pH <7.10 plus composite neonatal outcome AUC 0.76(95% CI:0.67-0.85), cut-off 4.8mmol/L. Conclusions Suggested intervention threshold for fetal acidemia is scalp lactate of 5.2mmol/L using the StatstripLactate®/StatstripXpress®.

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Clinical evaluation of Statstrip^® Lactate for use in fetal scalp blood sampling

Abstract: SSL is a reliable test to measure lactate in FBS with a low failure rate. As there are discrepancies between SSL and RLpH, and the cut-off values have not yet been evaluated prospectively regarding intervention rates and neonatal outcome, we recommend using SSL in addition to pH in FBS.

Cited by 11 publications

References 23 publications

Proposed cutoff for fetal scalp blood lactate in intrapartum fetal surveillance based on neonatal outcomes: a large prospective observational study

Proposed cutoff for fetal scalp blood lactate in intrapartum fetal surveillance based on neonatal outcomes: a large prospective observational study

Fetal lactate levels align with the stage of labour

Proposed cut-off for fetal scalp blood lactate in intrapartum fetal surveillance based on neonatal outcomes: a prospective observational study

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Clinical evaluation of Statstrip® Lactate for use in fetal scalp blood sampling

Abstract: SSL is a reliable test to measure lactate in FBS with a low failure rate. As there are discrepancies between SSL and RLpH, and the cut-off values have not yet been evaluated prospectively regarding intervention rates and neonatal outcome, we recommend using SSL in addition to pH in FBS.

Cited by 11 publications

References 23 publications

Proposed cutoff for fetal scalp blood lactate in intrapartum fetal surveillance based on neonatal outcomes: a large prospective observational study

Proposed cutoff for fetal scalp blood lactate in intrapartum fetal surveillance based on neonatal outcomes: a large prospective observational study

Fetal lactate levels align with the stage of labour

Proposed cut-off for fetal scalp blood lactate in intrapartum fetal surveillance based on neonatal outcomes: a prospective observational study

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Clinical evaluation of Statstrip^® Lactate for use in fetal scalp blood sampling