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

An observational study of Pregnancy Related, run by Hung Vuong Hospital at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Pregnancy Related
What is being tested?: complete blood count, PT, aPTT, fibrinogen tests
How many people: 879 participants
Where: 1 siteVietnam
Study dates: 9 Jun 2023to 21 Aug 2023
How long will I take part?: 1 Day
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Study population: pregnant women at obstetrics clinics at Hung Vuong Hospital

Who may be able to join

Singleton Pregnancy

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

Hung Vuong Hospital
Ho Chi Minh City, 700000

Other trials in Vietnam

About this study

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

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.

Read the 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 ethylenediamine tetraacetic acid (EDTA) 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 Clinical and Laboratory Standards Institute (CLSI) method and quality control is checked before in accordance to the laboratory procedure.

Statistical analysis: Patients were divided into three groups, which are first, second, and third trimester. CLSI EP28-A3c recommended Dixon's D/R ratio outlier test to exclude outliers, where D is the absolute difference between the largest (or smallest) and the second largest (or smallest) observation, and R is the range of all observations. If D is equal to or greater than one-third of R, that observation is considered an outlier and is deleted. After outliers were deleted, the remaining data was tested again for additional outliers until there were no more outliers. A non-parametric method, recommended to establish reference intervals by CLSI EP28-A3c, was used to determine the lower reference limit 2.5th percentile and upper reference limit 97.5th percentile for each group.

Each reference limit was reported along with its 90th confidence interval. Groups were then compared using normal approximation with continuous correction Mann-Whitney U. A two-tailed P-value < 0.05 was considered significant. Statistical analysis was performed using NCSS statistical software (Utah, USA) version 2023

Conditions: Pregnancy Related
Being tested: complete blood count, PT, aPTT, fibrinogen tests
Keywords: Reference intervals, pregnancy, complete blood count, coagulation tests

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05929326
Study group	Role	What they receive
First trimester		Pregnant women with gestational age ≤ 13 weeks and 6 days Receives: 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 Receives: Diagnostic Test: complete blood count, PT, aPTT, fibrinogen tests
Third trimester		Pregnant women with gestational age ≥ 28 weeks Receives: Diagnostic Test: complete blood count, PT, aPTT, fibrinogen tests

What is being measured

The primary outcome is the main question the study is designed to answer.

Trimester Specific Prothrombin Time Reference Interval
Prothrombin time in seconds, measured on ACL TOP 550 coagulation analyzer
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Each participant's blood samples are run immediately after phlebotomy within 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jun 202321 Aug 2023

First posted3 Jul 2023
Study start9 Jun 2023
Primary completion21 Aug 2023
Study completion21 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 879 participants (actual)
Target duration: 1 Day

IDs, dates and publications

ClinicalTrials.gov ID: NCT05929326
Sponsor's protocol ID: CS/HV/23/13
Status last verified: May 2025
First submitted: 22 Jun 2023
Last updated: 4 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: data collected will be available when study is completed

Publications

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.
PubMed 28169502
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.
PubMed 27061783
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.
PubMed 29303769
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.
PubMed 28605659
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.
PubMed 37951881

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Pregnancy Related trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Establishment of Reference Intervals of Complete Blood Count and Coagulation Tests in Pregnant Women at Hung Vuong Hospital
ClinicalTrials.gov ID: NCT05929326
Acronym / sponsor ID: CS/HV/23/13
Conditions: Pregnancy Related
Keywords: Reference intervals, pregnancy, complete blood count, coagulation tests
Study type: Observational
Recruitment status: Completed
Enrolment: 879 participants (actual)
Lead sponsor: Hung Vuong HospitalUniversity, hospital or other
Collaborators: MITALAB COMPANY LIMITED
Study start: 9 Jun 2023 (actual)
Primary completion: 21 Aug 2023 (actual)
Study completion: 21 Aug 2023 (actual)
First posted: 3 Jul 2023 (actual)
Results: Posted 4 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case only
Time perspective: Cross-sectional
Target follow-up: 1 Day
Number of arms: 3

Arm	Type	Receives
First trimester	–	Diagnostic Test: complete blood count, PT, aPTT, fibrinogen testsPregnant women with gestational age ≤ 13 weeks and 6 days
Second trimester	–	Diagnostic Test: complete blood count, PT, aPTT, fibrinogen testsPregnant women with gestational age from 14 weeks and 0 days to 27 weeks and 6 days
Third trimester	–	Diagnostic Test: complete blood count, PT, aPTT, fibrinogen testsPregnant women with gestational age ≥ 28 weeks

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: pregnant women at obstetrics clinics at Hung Vuong Hospital

Key inclusion criteria (1 listed)

Singleton Pregnancy

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
complete blood count, PT, aPTT, fibrinogen testsPregnant women who are eligible for the study will have their blood collected to run complete blood count, PT, aPTT, fibrinogen tests	Diagnostic test	First trimester, Second trimester, Third trimester

Primary outcome

Trimester Specific Prothrombin Time Reference Interval
Time frame: Each participant's blood samples are run immediately after phlebotomy within 30 minutes
Prothrombin time in seconds, measured on ACL TOP 550 coagulation analyzer
Trimester Specific Activated Partial Thromboplastin Time Reference Interval
Time frame: Each participant's blood samples are run immediately after phlebotomy within 30 minutes
Activated partial thromboplastin time in seconds, measured on ACL TOP 550 coagulation analyzer
Trimester Specific Fibrinogen Reference Interval
Time frame: Each participant's blood samples are run immediately after phlebotomy within 30 minutes
Fibrinogen in milligram/deciLiter (mg/dL), measured on ACL TOP 550 coagulation analyzer
Trimester Specific Hemoglobin Reference Interval
Time frame: Each participant's blood samples are run immediately after phlebotomy within 30 minutes
Hemoglobin in gram/deciLiter (g/dL), measured on DxH900 hematology analyzer
Trimester Specific Red Blood Cell Count Reference Interval
Time frame: Each participant's blood samples are run immediately after phlebotomy within 30 minutes
Red blood cell count in million cells/μl (M/μl), measured on DxH900 hematology analyzer
Trimester Specific White Blood Cell Count Reference Interval
Time frame: Each participant's blood samples are run immediately after phlebotomy within 30 minutes
White blood cell count in thousand cells/μl (K/μl), measured on DxH900 hematology analyzer
Trimester Specific Hematocrit Reference Interval
Time frame: Each participant's blood samples are run immediately after phlebotomy within 30 minutes
percentage of hematocrit (%), measured on DxH900 Hematology Analyzer
Trimester Specific Platelet Reference Interval
Time frame: Each participant's blood samples are run immediately after phlebotomy within 30 minutes
Platelet in thousand cells/microLiter (K/μl), Measured on DxH900 Hematology Analyzer

Results and safety

Results posted to the registry on 4 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
First Trimester	307	305
Second Trimester	279	276
Third Trimester	293	286

Primary outcome: Trimester Specific Prothrombin Time Reference Interval

Time frame: Each participant's blood samples are run immediately after phlebotomy within 30 minutes. Median (95% Confidence Interval). Unit: seconds

Measure	First Trimester n = 288	Second Trimester n = 269	Third Trimester n = 279
Value	11.40 (10.30 to 12.88)	10.60 (9.80 to 11.60)	10.40 (9.60 to 11.40)

Population analysed: A total of 879 patients were enrolled but 12 patients' samples failed to run, leaving 867 patients. Out of 867 patients, due to unqualified quality, 837 samples were eligible for complete blood count test and 836 samples for coagulation tests

Primary outcome: Trimester Specific Activated Partial Thromboplastin Time Reference Interval

Time frame: Each participant's blood samples are run immediately after phlebotomy within 30 minutes. Median (95% Confidence Interval). Unit: seconds

Measure	First Trimester n = 288	Second Trimester n = 269	Third Trimester n = 279
Value	30.10 (25.40 to 35.50)	27.90 (24.05 to 33.26)	27.10 (23.40 to 31.80)

Primary outcome: Trimester Specific Fibrinogen Reference Interval

Time frame: Each participant's blood samples are run immediately after phlebotomy within 30 minutes. Median (95% Confidence Interval). Unit: mg/dL

Measure	First Trimester n = 288	Second Trimester n = 269	Third Trimester n = 279
Value	404.56 (280.28 to 559.00)	450.00 (347.75 to 593.35)	480.30 (330.28 to 628.56)

Primary outcome: Trimester Specific Hemoglobin Reference Interval

Time frame: Each participant's blood samples are run immediately after phlebotomy within 30 minutes. Median (95% Confidence Interval). Unit: g/dL

Measure	First Trimester n = 287	Second Trimester n = 273	Third Trimester n = 277
Value	12.41 (10.33 to 13.95)	11.58 (9.71 to 13.17)	12.11 (9.80 to 13.97)

Adverse events

Time frame: Adverse events, including all-cause mortality, were not monitored or assessed during the study period. The study was limited to a one-time blood sample collection from each participant between June and August 2023, with no follow-up for adverse events.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
First Trimester	0 of 0	0 of 0
Second Trimester	0 of 0	0 of 0
Third Trimester	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28169502de 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.
Background: PubMed 27061783Gong 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.
Background: PubMed 29303769Jin 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.
Background: PubMed 28605659Cui 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.
Derived from this study: PubMed 37951881Pham 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.
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, 3rd EditionLink provided by the sponsor.
Individual participant dataSharing planned: Yes. data collected will be available when study is completed

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Huan N Pham, Doctor principal investigator

Hung Vuong Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy Related, run by Hung Vuong Hospital at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trimester Specific Prothrombin Time Reference Interval (time frame: Each participant's blood samples are run immediately after phlebotomy within 30 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05929326, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.