Iron supplements to prevent iron deficiency anemia in pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind trial compares an iron plus folic acid supplement to folic acid alone in healthy pregnant women, starting around week 11-13 and continuing until delivery. The goal is to see if iron helps maintain adequate hemoglobin and iron status throughout gestation. Enrollment targets roughly 162 participants and uses a 2:1 allocation in a parallel design with follow-up visits at 20-22 weeks and 28-30 weeks, plus a delivery-era assessment. Primary outcome is maintenance of hemoglobin; secondary outcomes include broader hematological parameters and pregnancy outcomes. The intervention is delivered as an orodispersible iron-based film.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Healthy Caucasian women aged 18-45 years.
2. Single, viable pregnancy.
3. Plasma ferritin levels in the first trimester ≤ 70 ng/mL.
4. Hb levels in the first trimester ≥ 110 g/L.
5. Understanding and signing of the informed consent.

Exclusion Criteria:

1. Anemia (Hb levels \< 110 g/L), adequate iron repletion (serum ferritin levels \> 70 ng/mL).
2. Multiple pregnancy (twins).
3. Known comorbidities or chronic therapy administered to the pregnant.
4. Maternal pathologies interfering with iron absorption (e.g. celiac disease, inflammatory bowel disease - IBD).
5. Abnormal Hb electrophoresis result.
6. Fetal anomalies detected during pregnancy.
7. Specific diets (e.g. gluten-free, vegan, or vegetarian).
8. Any nutritional supplement except for folic acid, vitamin D and/or isolated omega 3, and, in any case, based on the Investigator's case by-case evaluation.
9. Obesity (pre-pregnancy Body Mass index, BMI ≥ 30kg/m2).
10. Any clinical condition that is deemed not compatible with the study based on the Investigator's evaluation.

Where it's running

• SC Ostetricia - Clinica Mangiagalli, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  Milan, Italy Recruiting

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• Donor Breast Milk with Early Iron Supplementation in Very Preterm Infants

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.