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Clinical Trial Summary

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.


Clinical Trial Description

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 EDTA (ethylenediamine tetraacetic acid) 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 CLSI (Clinical and Laboratory Standards Institute) method and quality control is checked before in accordance to the laboratory procedure. Statistical analysis: CLSI document C28-A3c recommend establishing reference intervals using the 2.5th and 97.5th percentile of the distribution. The preferred method is nonparametric procedure, which does not need to exclude outliers. Each trimester RI will be compared to each other using z-test to determine if they are significantly different so that there must be seperate RI for each trimester. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05929326
Study type Observational [Patient Registry]
Source Hung Vuong Hospital
Contact Tri Bao Nguyen, Doctor
Phone +8402838558532
Email baotribvhv09@yahoo.com.vn
Status Recruiting
Phase
Start date June 1, 2023
Completion date September 15, 2023

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