Prevalence of iron deficiency in first trimester, nonanemic pregnant women.
Michael Auerbach, Jessica Abernathy, Sandra Juul...
https://pubmed.ncbi.nlm.nih.gov/31154873Actively Recruiting
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID06990373
Establishment of Reference Intervals for Iron Test Panel in Pregnant Women During First Trimester at Hung Vuong Hospital
Led by Hung Vuong Hospital · Updated on 2025-05-30
600
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to establish reference ranges for iron-related biomarkers such as serum iron, ferritin, total iron-binding capacity (TIBC), and transferrin saturation (TSAT) in healthy pregnant women during their first trimester. It also seeks to determine how common non-anemic iron deficiency (NAID) is among this group by carefully selecting participants to avoid factors that might affect iron levels. The study focuses on early pregnancy, a critical time for fetal development, to help improve iron deficiency detection before anemia develops. Pregnant women in their first trimester will be observed, including those who take iron supplements and those who do not. Data collection involves measuring hemoglobin and iron biomarkers at enrollment. The study is cross-sectional and observational, taking place at antenatal clinics from March to June 2025. Participants will be grouped based on iron supplement use to compare the prevalence of NAID and establish reliable reference intervals for iron status during early pregnancy. Participants will provide clinical data such as age, gestational age, body mass index, blood pressure, and body temperature. Blood tests will measure hemoglobin and iron markers. Researchers will analyze these results to calculate reference intervals and determine NAID prevalence, defined by specific ferritin and TSAT thresholds with normal hemoglobin levels. The study's findings aim to support better early detection and management of iron deficiency in pregnant women, with all data collected confidentially and ethical approval in place.
CONDITIONS
Brief Title
Iron Status of Non-anemic Pregnant Women in First Trimester
Who Can Participate
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Pregnant women attending antenatal care with a single live fetus
- Systolic blood pressure less than 140 mmHg at examination
- Diastolic blood pressure less than 90 mmHg at examination
- Body temperature between 35 0C and 37.5 0C at examination
- Hemoglobin level 11 g/dL or higher at enrollment
- Female aged 18 to 45 years
You will not qualify if you...
- History of diabetes mellitus, hypertension, hemoglobinopathies, leukemia, non-hematologic cancers, or systemic lupus erythematosus
- History of gastrointestinal diseases such as Celiac disease, Crohn's disease, ulcerative colitis, gastric diseases, prior gastrointestinal surgery, or irritable bowel syndrome
- Current use of gastric acid-suppressing medications including proton pump inhibitors or H2 receptor antagonists
- Positive screening for Treponema pallidum, HBsAg, or HIV
- Use of stimulants or tobacco smoking
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during routine antenatal care
Diagnostic Evaluation
Duration - At baseline (upon enrollment)
Participants undergo laboratory tests to measure iron biomarkers including serum iron, ferritin, total iron-binding capacity (TIBC), and transferrin saturation (TSAT) as well as hemoglobin levels.
1 baseline visit (in-person) during routine antenatal care
Long-term Monitoring
Duration - Up to 13 weeks 6 days (first trimester)
Participants who attend routine antenatal care are observed for iron status and prevalence of non-anemic iron deficiency during the first trimester of pregnancy.
Participants attend routine antenatal care visits as scheduled by their healthcare provider
Trial Site Locations
Total: 1 location
1
Hung Vuong Hospital
Ho Chi Minh City, Ho Chi Minh, Vietnam, 70000
Actively Recruiting
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Research Team
H
Huan Nguyen Pham, Master of medicine
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Iron homeostasis during pregnancy.
Allison L Fisher, Elizabeta Nemeth
https://pubmed.ncbi.nlm.nih.gov/29070542Serum ferritin thresholds for the diagnosis of iron deficiency in pregnancy: a systematic review.
J Daru, J Allotey, J P Peña-Rosas...
https://pubmed.ncbi.nlm.nih.gov/28425182Physiologically based trimester-specific serum ferritin thresholds for iron deficiency in US pregnant women.
Zuguo Mei, O Yaw Addo, Maria Elena D Jefferds...
https://pubmed.ncbi.nlm.nih.gov/38781318Iron deficiency.
Sant-Rayn Pasricha, Jason Tye-Din, Martina U Muckenthaler...
https://pubmed.ncbi.nlm.nih.gov/33285139