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

NCT05929326 | Completed Results DMC

• 1 other identifier: CS/HV/23/13
• Study Type: observational
• Target: 879
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

Reference intervals; pregnancy; complete blood count; coagulation tests

Outcome Measures

Primary Outcomes (8)

• Trimester Specific Prothrombin Time Reference Interval

  Prothrombin time in seconds, measured on ACL TOP 550 coagulation analyzer

  Each participant's blood samples are run immediately after phlebotomy within 30 minutes

• Trimester Specific Activated Partial Thromboplastin Time Reference Interval

  Activated partial thromboplastin time in seconds, measured on ACL TOP 550 coagulation analyzer

  Each participant's blood samples are run immediately after phlebotomy within 30 minutes

• Trimester Specific Fibrinogen Reference Interval

  Fibrinogen in milligram/deciLiter (mg/dL), measured on ACL TOP 550 coagulation analyzer

  Each participant's blood samples are run immediately after phlebotomy within 30 minutes

• Trimester Specific Hemoglobin Reference Interval

  Hemoglobin in gram/deciLiter (g/dL), measured on DxH900 hematology analyzer

  Each participant's blood samples are run immediately after phlebotomy within 30 minutes

• Trimester Specific Red Blood Cell Count Reference Interval

  Red blood cell count in million cells/μl (M/μl), measured on DxH900 hematology analyzer

  Each participant's blood samples are run immediately after phlebotomy within 30 minutes

• Trimester Specific White Blood Cell Count Reference Interval

  White blood cell count in thousand cells/μl (K/μl), measured on DxH900 hematology analyzer

  Each participant's blood samples are run immediately after phlebotomy within 30 minutes

• Trimester Specific Hematocrit Reference Interval

  percentage of hematocrit (%), measured on DxH900 Hematology Analyzer

  Each participant's blood samples are run immediately after phlebotomy within 30 minutes

• Trimester Specific Platelet Reference Interval

  Platelet in thousand cells/microLiter (K/μl), Measured on DxH900 Hematology Analyzer

  Each participant's blood samples are run immediately after phlebotomy within 30 minutes

Study Arms (3)

First trimester

Pregnant women with gestational age ≤ 13 weeks and 6 days

Diagnostic Test: complete blood count, PT, aPTT, fibrinogen tests

Second trimester

Pregnant women with gestational age from 14 weeks and 0 days to 27 weeks and 6 days

Diagnostic Test: complete blood count, PT, aPTT, fibrinogen tests

Third trimester

Pregnant women with gestational age ≥ 28 weeks

Diagnostic Test: complete blood count, PT, aPTT, fibrinogen tests

Interventions

complete blood count, PT, aPTT, fibrinogen tests DIAGNOSTIC_TEST

Pregnant women who are eligible for the study will have their blood collected to run complete blood count, PT, aPTT, fibrinogen tests

First trimester; Second trimester; Third trimester

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women at obstetrics clinics at Hung Vuong Hospital

You may qualify if:

• Singleton Pregnancy

You may not qualify if:

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

Sponsors & Collaborators

• Hung Vuong Hospital: lead
• MITALAB COMPANY LIMITED: collaborator

Study Sites (1)

Hung Vuong Hospital

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (5)

• de Haas S, Ghossein-Doha C, van Kuijk SM, van Drongelen J, Spaanderman ME. Physiological adaptation of maternal plasma volume during pregnancy: a systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2017 Feb;49(2):177-187. doi: 10.1002/uog.17360.

  PMID: 28169502 BACKGROUND

• Gong JM, Shen Y, He YX. Reference Intervals of Routine Coagulation Assays During the Pregnancy and Puerperium Period. J Clin Lab Anal. 2016 Nov;30(6):912-917. doi: 10.1002/jcla.21956. Epub 2016 Apr 7.

  PMID: 27061783 BACKGROUND

• Jin Y, Lu J, Jin H, Fei C, Xie X, Zhang J. Reference intervals for biochemical, haemostatic and haematological parameters in healthy Chinese women during early and late pregnancy. Clin Chem Lab Med. 2018 May 24;56(6):973-979. doi: 10.1515/cclm-2017-0804.

  PMID: 29303769 BACKGROUND

• Cui C, Yang S, Zhang J, Wang G, Huang S, Li A, Zhang Y, Qiao R. Trimester-specific coagulation and anticoagulation reference intervals for healthy pregnancy. Thromb Res. 2017 Aug;156:82-86. doi: 10.1016/j.thromres.2017.05.021. Epub 2017 May 24.

  PMID: 28605659 BACKGROUND

• Pham HN, Huynh NX, Pham PNH, Dang DNY, Cao LT, Huynh DM, Thoi HTT, Le OH, Beaupha SMC. Reference intervals of complete blood count and coagulation tests in Vietnamese pregnant women. BMC Pregnancy Childbirth. 2023 Nov 11;23(1):788. doi: 10.1186/s12884-023-06106-2.

  PMID: 37951881 DERIVED

Related Links

• Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, 3rd Edition

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (2 mL) were collected by plastic whole blood tube with spray-coated K2-EDTA (ethylenediamine tetraacetic acid) Blood samples (2 mL) were collected by plastic whole blood tube with spray-coated Trisodium citrate 3.2%

MeSH Terms

Interventions

Blood Cell Count; Partial Thromboplastin Time

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Blood Coagulation Tests

Results Point of Contact

• Title: Dr. Huan N Pham
• Organization: Hung Vuong Hospital

huanpmd@gmail.com

+84906884435

Study Officials

• Huan N Pham, Doctor

  Hung Vuong Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Technical supervisor

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: June 9, 2023
• Primary Completion: August 21, 2023
• Study Completion: August 21, 2023
• Last Updated: June 4, 2025
• Results First Posted: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 6 months after publication

Locations

VN (1)