Establishment of Reference Intervals of Complete Blood Count and Coagulation Tests in Pregnant Women at Hung Vuong Hospital

Hung Vuong Hospital1 个研究点分布在 1 个国家目标入组 879 人开始时间: 2023年6月9日最近更新: 2025年6月4日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Hung Vuong Hospital
入组人数: 879
试验地点: 1
主要终点: Trimester Specific Prothrombin Time Reference Interval

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Rationale: Pregnancy has major effects on physiology in women. There have been many studies that established reference intervals but none was done in Vietnam. The recommendation by CLSI C28-A3 is that if possible, each laboratory establishes its own reference intervals.

Objective: To establish the reference intervals of complete blood count parameters and Prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen.

Study design: This is a cross-sectional study.

Study population: Pregnant women with no history of disease and normal clinical findings.

详细描述

Reference intervals (RI) is defined as the central 95% interval of the distribution of values taken from a biological reference population. RI is established for each trimester. The sample needed for each trimester is at least 258 which adds up to 774 when combining three trimesters.

Pregnant women are selected if eligible from obstetrics clinics after history taking and clinical findings. After consent, their blood are then drawn by phlebotomist into an ethylenediamine tetraacetic acid (EDTA) and a trisodium citrate 3.2% blood tube. EDTA samples are run on DxH 900 hematology analyzer, manufactured by Beckman Coulter and citrate samples are run on ACL TOP 550 coagulation analyzer, manufactured by Werfen. The analyzers are verified by laboratory procedure, recommended by Clinical and Laboratory Standards Institute (CLSI) method and quality control is checked before in accordance to the laboratory procedure.

Statistical analysis

Patients were divided into three groups, which are first, second, and third trimester. CLSI EP28-A3c recommended Dixon's D/R ratio outlier test to exclude outliers, where D is the absolute difference between the largest (or smallest) and the second largest (or smallest) observation, and R is the range of all observations. If D is equal to or greater than one-third of R, that observation is considered an outlier and is deleted. After outliers were deleted, the remaining data was tested again for additional outliers until there were no more outliers. A non-parametric method, recommended to establish reference intervals by CLSI EP28-A3c, was used to determine the lower reference limit 2.5th percentile and upper reference limit 97.5th percentile for each group.

Each reference limit was reported along with its 90th confidence interval. Groups were then compared using normal approximation with continuous correction Mann-Whitney U. A two-tailed P-value < 0.05 was considered significant. Statistical analysis was performed using NCSS statistical software (Utah, USA) version 2023

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Cross Sectional

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Singleton Pregnancy

排除标准

•Hypertension, Diabetes, Preeclampsia, Gestational Diabetes, Hemoglobinopathy, Current Infection, Positive Screening for Treponema pallidum, Hepatitis B Virus, HIV, usage of anticoagulant drug.