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.

• Intravenous Ferric Carboxymaltose (FCM) (Drug): Participants assigned to this arm will receive intravenous (IV) ferric carboxymaltose (Ferinject) administered using a standardized, conservative volume and rate protocol to optimize safety and tolerability. Each 500 mg dose of Ferinject (equivalent to 10 mL of solution) will be aseptically diluted in 250 mL of sterile 0.9% Normal Saline (NS). This configuration achieves a final elemental iron concentration of approximately 2 mg/mL, adhering precisely to the manufacturer's strict chemical stability threshold, delivered over a minimum duration of 15 minutes. Administrations will be performed exclusively in a controlled clinical environment equipped with immediate cardiopulmonary resuscitation facilities. Participant vital signs, including blood pressure and heart rate, will be documented immediately prior to initiation, at the 5-minute mark, upon completion, and throughout a mandatory 30-minute post-infusion observation period to monitor for potential hypersensitivity or adverse reactio
• Iron Sucrose (IS) Infusion (Drug), also known as Blogen: "Participants assigned to this arm will receive intravenous (IV) iron sucrose (Blogen) utilizing a step-up safety protocol to minimize acute hypersensitivity risks. On Day 1 (Baseline), participants will receive an initial safety and tolerability dose of 100 mg of iron sucrose diluted in 100 mL of 0.9% Normal Saline (NS), infused intravenously over a minimum of 15 minutes. Participants will be monitored for at least 30 minutes post-infusion for acute adverse events or hypersensitivity reactions. In the absence of any safety signals or severe drug intolerance, subsequent doses will scale to 200 mg of iron sucrose diluted in 100 mL of 0.9% NS, administered via intravenous infusion over 30 minutes. This 200 mg dose will be administered twice weekly, with a strict minimum of 48 hours between consecutive administrations, to reach a total weekly dose of 400 mg, until the participant's predefined cumulative iron deficit target is achieved.

Primary outcomes

• Change from Baseline in Hemoglobin (Hb) Levels at 4 Weeks Post-Infusion [Baseline to 4 weeks post-infusion]: The mean increase in maternal hemoglobin concentrations (measured in g/dL) calculated by subtracting the baseline Hb level (pre-infusion) from the Hb level obtained 4 weeks after the completion of the assigned intravenous iron therapy (FCM vs. IS).

Secondary outcomes

• Iron Store Restoration: Change from Baseline in Serum Ferritin Levels at 4 Weeks Post-Infusion [Time Frame: Baseline to 4 weeks post-infusion]: The mean increase in serum ferritin levels (measured in ng/mL or mcg/L) to assess the restoration of internal iron stores, calculated as the difference between baseline values and 4 weeks post-infusion values.
• Safety and Tolerability: Incidence and Frequency of Treatment-Emergent Adverse Events (TEAEs) [From the start of the first infusion up to 4 weeks post-infusion]: The percentage of participants experiencing any localized adverse reactions (e.g., injection site discoloration, pain, burning) or systemic adverse reactions (e.g., hypersensitivity reactions, nausea, headache, transient hypotension, hypophosphatemia) during or following the infusion sessions.
• Treatment Burden :Total Number of Hospital Visits Required for Treatment Completion [1 month after completion of the full iron dose regimen]: The total count of separate outpatient hospital or clinic visits required for a participant to receive their full calculated cumulative dose of intravenous iron (comparing the single/dual dosing capability of FCM against the multiple lower-dose sessions required for IS).
• Maternal Treatment Satisfaction Score [1 month after completion of the full iron dose regimen]: Maternal treatment satisfaction and perceived treatment burden will be evaluated using a study-specific, 5-item structured questionnaire. To ensure cross-cultural validity and accurate comprehension within the regional study population, the questionnaire is translated and administered in both Kurdish Sorani and Kurdish Badini dialects. The assessment is divided into two operational phases: Phase 1 (Baseline Assessment - Day 0) measures the participant's pre-treatment status regarding current daily energy levels, physical fatigue, expectations of the infusion process, current symptom severity, and overall baseline physical well-being. Phase 2 (Follow-up Assessment - 1 Month Post-Treatment) evaluates post-infusion changes, specifically assessing improvements in energy levels, reduction in fatigue, satisfaction with the time and convenience/burden of the infusion process, symptom relief, and overall medical treatment satisfaction. Items are scored on a 1-5 scale (1=Very Dissatisfied, 5=

Sex: Female, ages: 18 Years to 45 Years

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:

  1. Intolerance to oral iron therapy (e.g., severe nausea, severe constipation, or gastrointestinal distress).
  2. 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).
  3. Late presentation in the third trimester (greater than 34 weeks gestation) requiring rapid correction of anemia.
  4. 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