Comparing Two Intravenous Iron Treatments for Anemia in Kurdish Pregnant Women

Официальное название

Comparison of Clinical Efficacy and Maternal Satisfaction: Intravenous Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anemia in a Sample of Kurdish Pregnant Women: A Multicenter, Randomized, Open-Label Trial With Blinded Outcome Assessment

Обзор

The goal of this clinical trial is to compare two types of intravenous (IV) iron-Ferric Carboxymaltose (FCM) and Iron Sucrose (IS)-to learn which one works better to treat iron deficiency anemia in pregnant women who have a clear medical need for IV iron. It will also learn about the safety of both drugs. The main questions it aims to answer are: 1. Does FCM lead to a higher increase in hemoglobin (blood iron) levels 4 weeks after treatment compared to IS? 2. What medical problems or side effects do women experience with each drug? 3. Does FCM reduce the number of hospital visits and improve women satisfaction? Participants will: 1. Be in their second or third trimester and share the same precise medical indications requiring IV iron (such as severe anemia, no improvement from pills, or being very late in their pregnancy). 2. Be randomly assigned from the start to receive either FCM or IS through an IV, with the total dose calculated based on their body weight and blood tests. 3. Receive FCM in one or more full doses, or receive IS split into multiple smaller sessions up to 3 times a week. 4. Visit the clinic for their assigned infusions and undergo blood tests and satisfaction surveys twice: right before starting treatment and 1 month after receiving the medication.

Подробное описание

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.

Вмешательства

• Препарат Intravenous Ferric Carboxymaltose (FCM)
  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 stabil
• Препарат Iron Sucrose (IS) Infusion
  "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.

Первичные конечные точки

• Change from Baseline in Hemoglobin (Hb) Levels at 4 Weeks Post-Infusion [Срок оценки: Baseline to 4 weeks post-infusion]

Вторичные конечные точки (4)

• Iron Store Restoration: Change from Baseline in Serum Ferritin Levels at 4 Weeks Post-Infusion [Срок оценки: Time Frame: Baseline to 4 weeks post-infusion]
• Safety and Tolerability: Incidence and Frequency of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: From the start of the first infusion up to 4 weeks post-infusion]
• Treatment Burden :Total Number of Hospital Visits Required for Treatment Completion [Срок оценки: 1 month after completion of the full iron dose regimen]
• Maternal Treatment Satisfaction Score [Срок оценки: 1 month after completion of the full iron dose regimen]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07721519 · HMU 5

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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