Trial Outcomes & Findings for Reference Intervals of Complete Blood Count and Coagulation Tests in Pregnant Women at Hung Vuong Hospital (NCT NCT05929326)

NCT ID: NCT05929326

Last Updated: 2025-06-04

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

879 participants

Primary outcome timeframe

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

Results posted on

2025-06-04

Participant Flow

Participant milestones

Participant milestones
Measure	First Trimester Pregnant women with gestational age ≤ 13 weeks and 6 days	Second Trimester Pregnant women with gestational age from 14 weeks and 0 days to 27 weeks and 6 days	Third Trimester Pregnant women with gestational age ≥ 28 weeks
Overall Study STARTED	307	279	293
Overall Study COMPLETED	305	276	286
Overall Study NOT COMPLETED	2	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	First Trimester Pregnant women with gestational age ≤ 13 weeks and 6 days	Second Trimester Pregnant women with gestational age from 14 weeks and 0 days to 27 weeks and 6 days	Third Trimester Pregnant women with gestational age ≥ 28 weeks
Overall Study unqualified sample	2	3	7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	First Trimester n=305 Participants Pregnant women with gestational age ≤ 13 weeks and 6 days complete blood count, prothrombin time (PT), activated partial thromboplastin time (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	Second Trimester n=276 Participants Pregnant women with gestational age from 14 weeks and 0 days to 27 weeks and 6 days complete blood count, prothrombin time (PT), activated partial thromboplastin time (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	Third Trimester n=286 Participants Pregnant women with gestational age ≥ 28 weeks complete blood count, prothrombin time (PT), activated partial thromboplastin time (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	Total n=867 Participants Total of all reporting groups
Age, Customized	28 years n=5 Participants	28 years n=7 Participants	29 years n=5 Participants	29 years n=4 Participants
Sex: Female, Male Female	305 Participants n=5 Participants	276 Participants n=7 Participants	286 Participants n=5 Participants	867 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Vietnamese	305 Participants n=5 Participants	276 Participants n=7 Participants	286 Participants n=5 Participants	867 Participants n=4 Participants
Region of Enrollment Vietnam	305 participants n=5 Participants	276 participants n=7 Participants	286 participants n=5 Participants	867 participants n=4 Participants
Gestational age	11 weeks n=5 Participants	25 weeks n=7 Participants	37 weeks n=5 Participants	25 weeks n=4 Participants

PRIMARY outcome

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

Population: 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

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

Outcome measures

Outcome measures
Measure	First Trimester n=288 Participants Pregnant women with gestational age ≤ 13 weeks and 6 days	Second Trimester n=269 Participants Pregnant women with gestational age from 14 weeks and 0 days to 27 weeks and 6 days	Third Trimester n=279 Participants Pregnant women with gestational age ≥ 28 weeks
Trimester Specific Prothrombin Time Reference Interval	11.40 seconds Interval 10.3 to 12.88	10.60 seconds Interval 9.8 to 11.6	10.40 seconds Interval 9.6 to 11.4

PRIMARY outcome

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

Population: 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

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

Outcome measures

Outcome measures
Measure	First Trimester n=288 Participants Pregnant women with gestational age ≤ 13 weeks and 6 days	Second Trimester n=269 Participants Pregnant women with gestational age from 14 weeks and 0 days to 27 weeks and 6 days	Third Trimester n=279 Participants Pregnant women with gestational age ≥ 28 weeks
Trimester Specific Activated Partial Thromboplastin Time Reference Interval	30.10 seconds Interval 25.4 to 35.5	27.90 seconds Interval 24.05 to 33.26	27.10 seconds Interval 23.4 to 31.8

PRIMARY outcome

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

Population: 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

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

Outcome measures

Outcome measures
Measure	First Trimester n=288 Participants Pregnant women with gestational age ≤ 13 weeks and 6 days	Second Trimester n=269 Participants Pregnant women with gestational age from 14 weeks and 0 days to 27 weeks and 6 days	Third Trimester n=279 Participants Pregnant women with gestational age ≥ 28 weeks
Trimester Specific Fibrinogen Reference Interval	404.56 mg/dL Interval 280.28 to 559.0	450.00 mg/dL Interval 347.75 to 593.35	480.30 mg/dL Interval 330.28 to 628.56

PRIMARY outcome

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

Population: 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

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

Outcome measures

Outcome measures
Measure	First Trimester n=287 Participants Pregnant women with gestational age ≤ 13 weeks and 6 days	Second Trimester n=273 Participants Pregnant women with gestational age from 14 weeks and 0 days to 27 weeks and 6 days	Third Trimester n=277 Participants Pregnant women with gestational age ≥ 28 weeks
Trimester Specific Hemoglobin Reference Interval	12.41 g/dL Interval 10.33 to 13.95	11.58 g/dL Interval 9.71 to 13.17	12.11 g/dL Interval 9.8 to 13.97

PRIMARY outcome

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

Population: 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

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

Outcome measures

Outcome measures
Measure	First Trimester n=287 Participants Pregnant women with gestational age ≤ 13 weeks and 6 days	Second Trimester n=273 Participants Pregnant women with gestational age from 14 weeks and 0 days to 27 weeks and 6 days	Third Trimester n=277 Participants Pregnant women with gestational age ≥ 28 weeks
Trimester Specific Red Blood Cell Count Reference Interval	4.35 M/μl Interval 3.73 to 5.32	3.91 M/μl Interval 3.33 to 4.98	4.18 M/μl Interval 3.54 to 4.98

PRIMARY outcome

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

Population: 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

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

Outcome measures

Outcome measures
Measure	First Trimester n=287 Participants Pregnant women with gestational age ≤ 13 weeks and 6 days	Second Trimester n=273 Participants Pregnant women with gestational age from 14 weeks and 0 days to 27 weeks and 6 days	Third Trimester n=277 Participants Pregnant women with gestational age ≥ 28 weeks
Trimester Specific White Blood Cell Count Reference Interval	9.50 K/μl Interval 6.33 to 15.24	10.77 K/μl Interval 6.99 to 15.55	9.48 K/μl Interval 6.22 to 14.14

PRIMARY outcome

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

Population: 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

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

Outcome measures

Outcome measures
Measure	First Trimester n=287 Participants Pregnant women with gestational age ≤ 13 weeks and 6 days	Second Trimester n=273 Participants Pregnant women with gestational age from 14 weeks and 0 days to 27 weeks and 6 days	Third Trimester n=277 Participants Pregnant women with gestational age ≥ 28 weeks
Trimester Specific Hematocrit Reference Interval	37.92 percent Interval 32.22 to 42.23	35.13 percent Interval 30.26 to 40.07	37.18 percent Interval 31.11 to 42.7

PRIMARY outcome

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

Population: 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

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

Outcome measures

Outcome measures
Measure	First Trimester n=287 Participants Pregnant women with gestational age ≤ 13 weeks and 6 days	Second Trimester n=273 Participants Pregnant women with gestational age from 14 weeks and 0 days to 27 weeks and 6 days	Third Trimester n=277 Participants Pregnant women with gestational age ≥ 28 weeks
Trimester Specific Platelet Reference Interval	268.80 K/μl Interval 169.66 to 413.88	257.70 K/μl Interval 172.34 to 372.19	249.20 K/μl Interval 151.3 to 417.16

Adverse Events

First Trimester

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Second Trimester

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Third Trimester

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Huan N Pham

Hung Vuong Hospital

Phone: +84906884435

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place