An interventional study of Intravenous Ferric Carboxymaltose (FCM) and Iron Sucrose (IS) Infusion in Iron Deficiency Anemia in Pregnancy, sponsored by Hawler Medical University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Hawler Medical University · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's planned enrollment of 400 is above the median of 100 across 459 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Hawler Medical University is the lead sponsor of 59 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Medical Indication for Intravenous (IV) Iron: Must meet at least one of the following specific clinical indications:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 maintenance 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.
Drug: Intravenous Ferric Carboxymaltose (FCM)
Participants assigned to this arm will receive intravenous (IV) iron sucrose (Blogen, 20 mg/mL concentration) utilizing a step-up safety sequence delivered via manual gravity drip. On Day 1 (Baseline), participants will receive an initial safety and tolerability check dose of 100 mg (5 mL) of iron sucrose diluted in 100 mL of sterile 0.9% Normal Saline (NS) and infused over a minimum of 15 minutes. Following a clinical evaluation to confirm the absence of acute hypersensitivity or infusion reactions, subsequent maintenance doses will escalate to 200 mg (10 mL) of iron sucrose. Each 200 mg maintenance dose will be diluted in 150 mL of sterile 0.9% NS, yielding a 160 mL total fluid volume with a stable iron concentration of 1.25 mg/mL (safely above the manufacturer's 1 mg/mL stability floor). The solution will be administered via an intravenous gravity drip set, with the flow rate manually calibrated and monitored by clinical staff to ensure the full volume is infused over exactly 30 mi
Drug: Iron Sucrose (IS) Infusion
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
"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.
Also known as: Blogen
Change from Baseline in Hemoglobin (Hb) Levels at 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).
Time frame: Baseline to 4 weeks post-infusion
Iron Store Restoration: Change from Baseline in Serum Ferritin Levels at 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.
Time frame: Time Frame: Baseline to 4 weeks post-infusion
Safety and Tolerability: Incidence and Frequency of Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: From the start of the first infusion up to 4 weeks post-infusion
Treatment Burden :Total Number of Hospital Visits Required for Treatment Completion
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).
Time frame: 1 month after completion of the full iron dose regimen
Maternal Treatment Satisfaction Score
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=
Time frame: 1 month after completion of the full iron dose regimen
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Mar 2028, 18 months later.
Of 132 non-industry interventional studies with no phase under Anemia, Iron-Deficiency, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's planned 18 months is above that.
Counting every sponsor, half of 141 studies reached it within 11 months; a quarter within 3 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ferric carboxymaltose · Iron sucrose
Hawler Medical University