2025/10/26 by Sofie Gellert, Sara Norrestam, Alexandra Tidstedt +4
paper · doi:10.1111/aogs.70080
crossref issued 2025/10/26 · crossref published 2025/10/26 · crossref published-online 2025/10/26 · crossref created 2025/10/27 · crossref published-print 2025/12/01 · crossref deposited 2025/12/02 · crossref indexed 2026/08/01
Abstract Introduction This multicenter, prospective observational study aimed to evaluate the performance of the StatStrip ® Lactate 2 (Nova Biomedical, Waltham, US) point‐of‐care device for fetal blood lactate measurement and to determine the corresponding lactate value equivalent to the established intervention cutoff used with the outgoing StatStrip ® Lactate device. Material and Methods The study was conducted from August 2024 to February 2025 at two maternity clinics in Sweden and one in Denmark. It included women with singleton pregnancies (≥35 + 0 weeks) undergoing fetal blood sampling due to non‐reassuring intrapartal fetal heart rate patterns during labor. Fetal scalp blood sampling (FBS) lactate concentrations were measured using both StatStrip ® Lactate and StatStrip ® Lactate2. The first StatStrip ® Lactate measurement guided clinical decisions, while subsequent StatStrip ® Lactate2 measurements were recorded for validation and establishment of a conversion equation by linear regression. Additionally, arterial and venous umbilical cord blood samples were analyzed by both ABL 800 (Radiometer, Denmark) and StatStrip ® Lactate2 for validation. Results Blood samples from 349 fetuses were included, with 549 parallel FBS lactate samples. StatStrip ® Lactate2 concentrations correlated with StatStrip ® Lactate ( r = 0.94; p ≤ 0.001). A conversion equation was retrieved: StatStrip ® Lactate2 = (1.4 × StatStrip ® Lactate) − 0.28. From 37 paired umbilical cord blood samples, the correlation between lactate concentrations by StatStrip ® Lactate2 and ABL800 was r = 0.99 ( p ≤ 0.001) in arterial blood and r = 0.98 ( p ≤ 0.001) in venous blood. Mean coefficients of variation for lactate concentrations >3.0 mmol/L were 8.2% in fetal scalp blood and 3.8% in umbilical cord blood. Conclusions A fetal blood lactate concentration ≥7.0 mmol/L measured by StatStrip ® Lactate2 corresponds to the established intervention cutoff lactate value ≥5.2 mmol/L measured by StatStrip ® Lactate. Precision was acceptable but may be improved by using the mean of two measurements, particularly when the first result falls between 6.0 and 8.0 mmol/L. We also recommend ensuring the correct sampling techniques to minimize preanalytical variation.