Oral Versus Intravenous Iron for Anemia Diagnosed After 34 Weeks of Gestation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Roma La Sapienza

About this trial

This study aims to address this evidence gap by comparing a step-up oral-first strategy with an early IV iron strategy in pregnant women diagnosed with anemia after 34 weeks of gestation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Women aged 18 years or older.

Singleton pregnancy.

Gestational age ≥34+0 weeks at the time of anemia diagnosis.

Hemoglobin <11 g/dL measured as part of routine antenatal care.

Disqualifiers

• Known anemia not primarily due to iron deficiency.

Known hemoglobinopathies.

Severe anemia requiring immediate blood transfusion.

Previous severe hypersensitivity reaction to IV iron formulations.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral iron supplementation

    Drug

    Participants randomized to this group will begin oral iron therapy immediately after diagnosis. The formulation and dosage will follow institutional practice and guideline recommendations

  • IV iron administration

    Drug

    Participants randomized to this group will receive IV iron within 7 days of diagnosis. The dose will be calculated based on body weight and estimated iron deficit. Oral iron supplementation is not mandated following IV administration.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Oral Iron SupplementationExperimental treatment 1 intervention
Group B: IV IronActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hemoglobin concentration (g/dL) measured at hospital admission for delivery.

Time frame
Delivery Hospitalization Day 1

Secondary outcomes

1

Hemoglobin concentration (g/dL) at 38+0 weeks of gestation

Time frame
At 38+0 weeks of gestation
2

Postpartum hemoglobin concentration (g/dL)

Time frame
Postpartum Day 1
3

Absolute change in hemoglobin

Time frame
At delivery hospitalization
4

Peripartum Blood Transfusion

Time frame
Peripeocedural

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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