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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pregnancy Related

Intervention / Treatment
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* Diagnostic Test: complete blood count, PT, aPTT, fibrinogen tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton Pregnancy Exclusion Criteria: Hypertension, Diabetes, Preeclampsia, Gestational Diabetes, Hemoglobinopathy, Current Infection, Positive Screening for Treponema pallidum, Hepatitis B Virus, HIV, usage of anticoagulant drug.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: complete blood count, PT, aPTT, fibrinogen tests|Pregnant women who are eligible for the study will have their blood collected to run complete blood count, PT, aPTT, fibrinogen tests|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trimester specific Prothrombin time reference interval | Prothrombin time in seconds | Each participant's blood samples are run immediately after phlebotomy | 
| Trimester specific Activated partial thromboplastin time reference interval | Activated partial thromboplastin time in seconds | Each participant's blood samples are run immediately after phlebotomy | 
| Trimester specific Fibrinogen reference interval | Fibrinogen in miligram/deciLiter (mg/dL) | Each participant's blood samples are run immediately after phlebotomy | 
| Trimester specific Hemoglobin reference interval | Hemoglobin in gram/deciLiter (g/dL) | Each participant's blood samples are run immediately after phlebotomy | 
| Trimester specific red blood cell count reference interval | Red blood cell count in million cells/microLiter (M/μl) | Each participant's blood samples are run immediately after phlebotomy | 
| Trimester specific white blood cell count reference interval | White blood cell count in thousand cells/microLiter (K/μl) | Each participant's blood samples are run immediately after phlebotomy | 
| Trimester specific hematocrit reference interval | Hematocrit in percent (%) | Each participant's blood samples are run immediately after phlebotomy | 
| Trimester specific platelet reference interval | Platelet in thousand cells/microLiter (K/μl) | Each participant's blood samples are run immediately after phlebotomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reference intervals, pregnancy, complete blood count, coagulation tests