Department of Clinical Biochemistry, Saolta University Health Care Group (SUHCG), 58040Galway University Hospitals, Galway, Ireland.
School of Medicine, 8799National University of Ireland Galway (NUIG), Galway, Ireland.
Ann Clin Biochem. 2022 Nov;59(6):433-446. doi: 10.1177/00045632221128686. Epub 2022 Oct 4.
Pregnancy induces physiological changes which affect biochemical and haematological parameters. As the significance of laboratory test results change throughout pregnancy, the reference interval (RI) or key result interpretive guide should be specific to pregnancy. This study sought to establish trimester-specific-RIs for routine biochemical and haematological tests in healthy white European women with singleton pregnancies with comparison to RIs for non-pregnant European adults.
A retrospective analysis of a prospective longitudinal single-centre study of healthy pregnant women conducted between November 2018 and December 2020 in a tertiary academic hospital with approximately 3000 births annually. Inclusion criteria: signed informed consent, age ≥18 years, white European, body mass index (BMI) <25 kg/m2, blood pressure <140/90mmHg, non-smoker, no previous pathology or gestational diabetes. Trimester defined as T1: up to 13 weeks + 6 days, T2: 14-27 weeks + 6 days and T3: ≥28-41 weeks + 6 days. Baseline demographics, anthropometric and laboratory measurements were recorded. In total, 31 biochemical and 10 haematological ISO15189:2012 accredited tests were measured using Roche Cobas® and Sysmex XN-9100™ analysers, respectively. RIs were established according to the International Federation of Clinical Chemistry (IFCC) recommended method.
Apparently healthy pregnant women ( = 124) with bio-banked serum samples in each trimester were recruited. At the booking visit, 49.2% ( = 61) of participants were nulliparous, with median age of 34.4 (IQR: 31.3-37.3) years, gestational age of 89 (IQR: 84-93) days, BMI of 22.5 (IQR: 21.0-23.7) kg/m and systolic and diastolic blood pressure of 116 (110-125) mmHg and 67 (61-75) mmHg, respectively.
Normative trimester-specific biological intervals for routinely requested biochemical and haematological medical laboratory tests were established. These RIs will be invaluable to result interpretation and the management of pregnant women.
妊娠会引起影响生化和血液参数的生理变化。由于实验室检测结果的意义在整个妊娠期间发生变化，因此参考区间（RI）或关键结果解释指南应针对妊娠情况具体制定。本研究旨在为白人欧洲单胎妊娠健康女性建立特定于妊娠阶段的常规生化和血液检测 RI，并与非妊娠欧洲成年人的 RI 进行比较。
这是一项在一家每年约有 3000 例分娩的三级学术医院进行的前瞻性纵向单中心研究的回顾性分析，研究对象为 2018 年 11 月至 2020 年 12 月期间签署知情同意书的健康白人欧洲孕妇，年龄≥18 岁，BMI<25kg/m2，血压<140/90mmHg，不吸烟，无既往病史或妊娠糖尿病。妊娠阶段定义为 T1：≤13 周+6 天，T2：14-27 周+6 天，T3：≥28-41 周+6 天。记录基线人口统计学、人体测量学和实验室测量数据。共测量了罗氏 Cobas®和希森美康 XN-9100™分析仪上的 31 项生化和 10 项血液学 ISO15189:2012 认可的检测项目。RI 根据国际临床化学联合会（IFCC）推荐的方法建立。
招募了每个妊娠阶段均有生物银行血清样本的健康孕妇（=124 名）。在预约就诊时，49.2%（=61 名）的参与者为初产妇，中位年龄为 34.4（IQR：31.3-37.3）岁，孕龄为 89（IQR：84-93）天，BMI 为 22.5（IQR：21.0-23.7）kg/m2，收缩压和舒张压分别为 116（110-125）mmHg 和 67（61-75）mmHg。
建立了常规生化和血液学医学实验室检测的特定于妊娠阶段的正常参考区间。这些 RI 将对妊娠妇女的结果解释和管理非常有价值。
