RecruitingNot Applicable

Iron Status of Non-anemic Pregnant Women in First Trimester

Vietnam600 participantsStarted 2025-03-12

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * Hemoglobin ≥ 11 g/dL Exclusion Criteria: * 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.

What they're measuring

Prevalence of iron supplement using women that has non-anemic iron deficiency in the first trimester

Timeframe: At baseline (upon enrollment)

Prevalence of non iron supplement using women that has non-anemic iron deficiency in the first trimester

Timeframe: At baseline (upon enrollment)

Reference Intervals for Iron Biomarkers in the First Trimester

Timeframe: At baseline (upon enrollment)

Trial details

NCT IDNCT06990373

SponsorHung Vuong Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-30

Contact for this trial

Huan Nguyen Pham, Master of medicine

+849068844435 huanpmd@gmail.com

View on ClinicalTrials.gov More Iron Deficiency (Without Anemia) trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Prevalence of iron supplement using women that has non-anemic iron deficiency in the first trimester

Timeframe: At baseline (upon enrollment)

Prevalence of non iron supplement using women that has non-anemic iron deficiency in the first trimester

Timeframe: At baseline (upon enrollment)

Reference Intervals for Iron Biomarkers in the First Trimester

Timeframe: At baseline (upon enrollment)