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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05929326
• Other study ID #: CS/HV/23/13
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: June 2023
• Source: Hung Vuong Hospital
• Contact: Tri Bao Nguyen, Doctor
• Phone: +8402838558532
• Email: baotribvhv09[@]yahoo.com.vn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 810
• Est. completion date: September 15, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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

Locations

Country	Name	City	State
Vietnam	Hung Vuong Hospital	Ho Chi Minh

Sponsors (2)

Lead Sponsor	Collaborator
Hung Vuong Hospital	MITALAB COMPANY LIMITED

Country where clinical trial is conducted

Vietnam, 

References & Publications (4)

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. — View Citation

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.1736 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trimester specific Prothrombin time reference interval	Prothrombin time in seconds	Each participant's blood samples are run immediately after phlebotomy
Primary	Trimester specific Activated partial thromboplastin time reference interval	Activated partial thromboplastin time in seconds	Each participant's blood samples are run immediately after phlebotomy
Primary	Trimester specific Fibrinogen reference interval	Fibrinogen in miligram/deciLiter (mg/dL)	Each participant's blood samples are run immediately after phlebotomy
Primary	Trimester specific Hemoglobin reference interval	Hemoglobin in gram/deciLiter (g/dL)	Each participant's blood samples are run immediately after phlebotomy
Primary	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
Primary	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
Primary	Trimester specific hematocrit reference interval	Hematocrit in percent (%)	Each participant's blood samples are run immediately after phlebotomy
Primary	Trimester specific platelet reference interval	Platelet in thousand cells/microLiter (K/µl)	Each participant's blood samples are run immediately after phlebotomy

External Links

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