N/A N=879

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

Pregnancy Related

Bottom Line

View on ClinicalTrials.gov: NCT05929326 ↗

Enrolled (actual)

879

Serious AEs

—

Results posted

Jun 2025

Primary outcome: Primary: Trimester Specific Prothrombin Time Reference Interval — 11.40; 10.60; 10.40 seconds

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: complete blood count, PT, aPTT, fibrinogen tests (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Hung Vuong Hospital
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Trimester Specific Prothrombin Time Reference Interval	11.40; 10.60; 10.40	—
PRIMARY Trimester Specific Activated Partial Thromboplastin Time Reference Interval	30.10; 27.90; 27.10	—
PRIMARY Trimester Specific Fibrinogen Reference Interval	404.56; 450.00; 480.30	—
PRIMARY Trimester Specific Hemoglobin Reference Interval	12.41; 11.58; 12.11	—
PRIMARY Trimester Specific Red Blood Cell Count Reference Interval	4.35; 3.91; 4.18	—
PRIMARY Trimester Specific White Blood Cell Count Reference Interval	9.50; 10.77; 9.48	—
PRIMARY Trimester Specific Hematocrit Reference Interval	37.92; 35.13; 37.18	—
PRIMARY Trimester Specific Platelet Reference Interval	268.80; 257.70; 249.20	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05929326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.