Iron Deficiency Anemia in Pregnancy
Conditions
Keywords
Iron Deficiency Anemia, Patient Satisfaction, Serum Ferritin, Randomized Controlled Trial, Ganzoni Formula, Iron Sucrose, Ferric Carboxymaltose, Intravenous Iron Therapy, Maternal Health, Third Trimester Anemia, Second Trimester Anemia
Brief summary
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.
Detailed description
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.
Interventions
DRUGIntravenous 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 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
DRUGIron 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. 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.
Sponsors
Hawler Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The laboratory personnel responsible for processing and analyzing the primary and secondary hematological outcomes (including Hemoglobin and Serum Ferritin levels) are fully blinded to the treatment arm assignments. Additionally, the data analysts performing the statistical evaluation of both the clinical data and the maternal satisfaction surveys will remain blinded to the participant group allocations until the final database lock.
Intervention model description
This is a 2-arm, parallel-assignment, open-label with blinded outcome assessment , randomized controlled trial. Eligible pregnant participants with a confirmed medical indication for IV iron therapy are randomized at baseline to one of two treatment groups: Group A receives intravenous Ferric Carboxymaltose (FCM) and Group B receives intravenous Iron Sucrose (IS). Both groups follow an identical schedule, with clinical, laboratory, and satisfaction evaluations conducted at baseline (pre-infusion) and at a follow-up visit exactly 4 weeks post-infusion
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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= |
Contacts
CONTACTSHAHLA KAREEM ALALAF, PROFESSOR
CONTACTRAQIB HUSEIN
Outcome results
None listed