Iron Status of Non-anemic Pregnant Women in First Trimester

NCT06990373 | Recruiting

• 1 other identifier: CS/HV/24/42
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iron Deficiency Without Anemia; Reference Values

Keywords

NAID; IDWA; Iron deficiency; Pregnant

Outcome Measures

Primary Outcomes (3)

• 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

  At baseline (upon enrollment)

• 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

  At baseline (upon enrollment)

• 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

  At baseline (upon enrollment)

Study Arms (2)

With iron supplement

Pregnant women who are taking iron supplement

Without iron supplement

Pregnant women who are not taking any iron supplement

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hung Vuong Hospital: lead

Study Sites (1)

Hung Vuong Hospital

Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam

RECRUITING

Related Publications (5)

• Auerbach M, Abernathy J, Juul S, Short V, Derman R. Prevalence of iron deficiency in first trimester, nonanemic pregnant women. J Matern Fetal Neonatal Med. 2021 Mar;34(6):1002-1005. doi: 10.1080/14767058.2019.1619690. Epub 2019 Jun 3.

  PMID: 31154873 BACKGROUND

• Fisher AL, Nemeth E. Iron homeostasis during pregnancy. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1567S-1574S. doi: 10.3945/ajcn.117.155812. Epub 2017 Oct 25.

  PMID: 29070542 BACKGROUND

• Daru J, Allotey J, Pena-Rosas JP, Khan KS. Serum ferritin thresholds for the diagnosis of iron deficiency in pregnancy: a systematic review. Transfus Med. 2017 Jun;27(3):167-174. doi: 10.1111/tme.12408. Epub 2017 Apr 20.

  PMID: 28425182 BACKGROUND

• Mei Z, Addo OY, Jefferds MED, Flores-Ayala RC, Brittenham GM. Physiologically based trimester-specific serum ferritin thresholds for iron deficiency in US pregnant women. Blood Adv. 2024 Jul 23;8(14):3745-3753. doi: 10.1182/bloodadvances.2024013460.

  PMID: 38781318 BACKGROUND

• Pasricha SR, Tye-Din J, Muckenthaler MU, Swinkels DW. Iron deficiency. Lancet. 2021 Jan 16;397(10270):233-248. doi: 10.1016/S0140-6736(20)32594-0. Epub 2020 Dec 4.

  PMID: 33285139 BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Huan Nguyen Pham, Master of medicine

CONTACT

+849068844435; huanpmd@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: May 25, 2025
• Study Start: March 12, 2025
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Individual participant data will be made available beginning 6 months after publication of the main study results and will remain accessible. Data requests during this time will be reviewed and approved by the principal investigator and ethics board, subject to a data use agreement.
• Access Criteria: De-identified individual participant data (IPD) will be made publicly available via a trusted data repository (e.g., Figshare) beginning 6 months after publication. No specific request or proposal is required for access. Users will be able to freely download the dataset under a standard data use license (e.g., Creative Commons Attribution \[CC BY 4.0\]). All shared data will be stripped of personal identifiers to protect participant confidentiality. A link to the dataset will be provided in the publication and on institutional or project websites.

Locations

VN (1)