Iron Status of Non-anemic Pregnant Women in First Trimester
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorHung Vuong Hospital
About this trial
This cross-sectional study aims to establish reference intervals for iron biomarkers-including serum iron, ferritin, total iron-binding capacity (TIBC), and transferrin saturation (TSAT)-in healthy pregnant women during the first trimester. Additionally, the study will investigate the current prevalence of non-anemic iron deficiency (NAID) in this population. By applying strict inclusion and exclusion criteria to eliminate potential confounding factors, the study seeks to provide a reliable baseline for evaluating iron status and early detection of iron deficiency without anemia among pregnant women.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant women attending antenatal care, carrying a single live fetus.
Systolic blood pressure at the time of examination < 140 mmHg.
Diastolic blood pressure at the time of examination < 90 mmHg.
Body temperature at the time of examination between >35°C and <37.5°C.
Disqualifiers
History of diabetes mellitus, hypertension, hemoglobinopathies, leukemia, non-hematologic cancers, systemic lupus erythematosus, Gastrointestinal diseases (Celiac disease, Crohn's disease and ulcerative colitis, Gastric diseases or prior gastrointestinal surgery, Irritable bowel syndrome, etc).
Currently on gastric acid-suppressing medications: Proton pump inhibitors (e.g., Omeprazole, Lansoprazole, Esomeprazole...), H2 receptor antagonists (e.g., Ranitidine, Famotidine, Cimetidine...), Positive screening for Treponema pallidum, HBsAg, or HIV.
Use of stimulants or tobacco smoking.
Trial population
Pregnant women
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 2 trial groupsGroup A: With iron supplement
Group B: Without iron supplement
Trial outcomes
Primary outcomes
1
Prevalence of iron supplement using women that has non-anemic iron deficiency in the first trimester
Non-anemic iron deficiency is defined as hemoglobin ≥ 11 g/dL and transferrin saturation (TSAT) \< 20%. The prevalence will be calculated as the proportion of enrolled pregnant women meeting these criteria
Time frame
At baseline (upon enrollment)2
Prevalence of non iron supplement using women that has non-anemic iron deficiency in the first trimester
Non-anemic iron deficiency is defined as hemoglobin ≥ 11 g/dL and transferrin saturation (TSAT) \< 20%. The prevalence will be calculated as the proportion of enrolled pregnant women meeting these criteria
Time frame
At baseline (upon enrollment)3
Reference Intervals for Iron Biomarkers in the First Trimester
Establish reference intervals (2.5th-97.5th percentile) for serum iron, ferritin, TIBC, and TSAT in healthy first-trimester pregnant women meeting inclusion criteria
Time frame
At baseline (upon enrollment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov