Establishment of Reference Intervals of Complete Blood Count and Coagulation Tests in Pregnant Women at Hung Vuong Hospital
- Conditions
- Pregnancy Related
- Registration Number
- NCT05929326
- Lead Sponsor
- Hung Vuong Hospital
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 810
- Singleton Pregnancy
- Hypertension, Diabetes, Preeclampsia, Gestational Diabetes, Hemoglobinopathy, Current Infection, Positive Screening for Treponema pallidum, Hepatitis B Virus, HIV, usage of anticoagulant drug.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Trimester specific Fibrinogen reference interval Each participant's blood samples are run immediately after phlebotomy Fibrinogen in miligram/deciLiter (mg/dL)
Trimester specific Hemoglobin reference interval Each participant's blood samples are run immediately after phlebotomy Hemoglobin in gram/deciLiter (g/dL)
Trimester specific red blood cell count reference interval Each participant's blood samples are run immediately after phlebotomy Red blood cell count in million cells/microLiter (M/μl)
Trimester specific Activated partial thromboplastin time reference interval Each participant's blood samples are run immediately after phlebotomy Activated partial thromboplastin time in seconds
Trimester specific white blood cell count reference interval Each participant's blood samples are run immediately after phlebotomy White blood cell count in thousand cells/microLiter (K/μl)
Trimester specific platelet reference interval Each participant's blood samples are run immediately after phlebotomy Platelet in thousand cells/microLiter (K/μl)
Trimester specific Prothrombin time reference interval Each participant's blood samples are run immediately after phlebotomy Prothrombin time in seconds
Trimester specific hematocrit reference interval Each participant's blood samples are run immediately after phlebotomy Hematocrit in percent (%)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hung Vuong Hospital
🇻🇳Ho Chi Minh, Vietnam