Comparing Two Intravenous Iron Treatments for Anemia in Kurdish Pregnant Women

This multicenter, open-label, blinded outcome assessment, randomized controlled trial is designed to evaluate the clinical impact, safety, and operational advantages of two distinct intravenous (IV) iron formulations for treating Iron Deficiency Anemia (IDA) during pregnancy. The study focuses on a specific women population within the Kurdistan region, Iraq who present with clear, established medical indications for IV iron therapy.

Upon meeting the required clinical thresholds, participants are randomized from the outset into one of two parallel treatment arms to receive their total calculated iron deficit, determined via the Ganzoni formula. Participants assigned to the FCM group receive Ferric Carboxymaltose administered in higher-dose, single or minimal-session infusions of up to 500 mg per session. Participants assigned to the IS group receive Iron Sucrose administered in sequential, lower-dose divided infusions of(100 or 200 mg per session), up to 3 times per week. All infusions are administered at the respective maternity teaching hospitals in Erbil, Sulaymaniyah, Duhok, or Zakho, with medical staff monitoring for immediate adverse reactions.

DATA COLLECTION AND TIMELINE Clinical evaluations are strictly timed to assess immediate and short-term hematological and person-centered responses. Initial blood test parameters, including Hemoglobin and Serum Ferritin, are recorded alongside baseline women surveys before any medication is administered. Exactly 4 weeks following the completion of the assigned treatment regimen, participants return for repeat blood tests to quantify hematological restoration, safety monitoring to log any delayed side effects, and a comprehensive survey to evaluate overall participants satisfaction and total hospital visit burdens.

Inclusion criteria

• Parity: All parity levels accepted (Para 0, Para 1, Para 2-4, and Para 5 or more).
• Pregnancy Stage: Currently in the second or third trimester of pregnancy (greater than 14 weeks gestation).
• Confirmed Iron Deficiency Anemia (IDA): Documented Hemoglobin (Hb) less than 11 g/dL AND Serum Ferritin less than 30 ng/mL.
• Medical Indication for Intravenous (IV) Iron: Must meet at least one of the following specific clinical indications:

• Intolerance to oral iron therapy (e.g., severe nausea, severe constipation, or gastrointestinal distress).
• Failure to respond to oral iron therapy (defined as a Hemoglobin increase of less than 1 g/dL after 3 weeks of compliant oral intake).
• Late presentation in the third trimester (greater than 34 weeks gestation) requiring rapid correction of anemia.
• Moderate to severe anemia at presentation (defined as Hemoglobin less than 9.0 g/dL).

Exclusion criteria

• First trimester of pregnancy (less than or equal to 14 weeks gestation).
• Known hypersensitivity, allergy, or previous severe adverse reaction to intravenous iron formulations or any of their components.
• Anemia due to causes other than iron deficiency (e.g., vitamin B12 or folate deficiency, hemoglobinopathies, anemia of chronic disease).
• Active, severe systemic infection.
• Relevant medical exclusions , such as severe hepatic or renal impairments