Assessing Iron Levels in Pregnant Women During Early Pregnancy
Establishment of Reference Intervals for Iron Test Panel for Pregnant Women at Hung Vuong Hospital
This study is trying to find out the normal iron levels in healthy pregnant women during their first trimester to help spot iron deficiency early on.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Hung Vuong Hospital Academic / other |
| Locations | 1 site (Ho Chi Minh City, Ho Chi Minh) |
| Trial ID | NCT06990373 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish reference intervals for iron biomarkers such as serum iron, ferritin, total iron-binding capacity (TIBC), and transferrin saturation (TSAT) in healthy pregnant women during their first trimester. It will also investigate the prevalence of non-anemic iron deficiency (NAID) in this population. By applying strict inclusion and exclusion criteria, the study seeks to provide a reliable baseline for evaluating iron status and early detection of iron deficiency without anemia among pregnant women. The study will take place at antenatal care clinics at Hung Vuong Hospital in Ho Chi Minh City, Vietnam, from March to June 2025.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women in their first trimester who are carrying a single live fetus and have a hemoglobin level of 11 g/dL or higher.
Not a fit: Patients with a history of certain medical conditions such as diabetes, hypertension, or gastrointestinal diseases, as well as those on specific medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of iron deficiency in pregnant women, potentially enhancing maternal and fetal health outcomes.
How similar studies have performed: While there is limited data on the prevalence of non-anemic iron deficiency in early pregnancy, similar studies have successfully established reference intervals for iron biomarkers in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ho Chi Minh City, Ho Chi Minh
- Hung Vuong Hospital — Ho Chi Minh City, Ho Chi Minh, Vietnam (Recruiting)
Study contacts
- Study coordinator: Huan Nguyen Pham, Master of medicine
- Email: huanpmd@gmail.com
- Phone: +849068844435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.