Iron Deficiency Anemia in PregnancyNCT07721519
Comparing Two Intravenous Iron Treatments for Anemia in Kurdish Pregnant Women
A study testing Intravenous Ferric Carboxymaltose (FCM) and Iron Sucrose (IS) Infusion in people with Iron Deficiency Anemia in Pregnancy, run by Hawler Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Iron Deficiency Anemia in Pregnancy
- What is being tested?
- Intravenous Ferric Carboxymaltose (FCM) and Iron Sucrose (IS) Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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:
- Does FCM lead to a higher increase in hemoglobin (blood iron) levels 4 weeks after treatment compared to IS?
- What medical problems or side effects do women experience with each drug?
- Does FCM reduce the number of hospital visits and improve women satisfaction?
Read more
Participants will:
- 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).
- 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.
- Receive FCM in one or more full doses, or receive IS split into multiple smaller sessions up to 3 times a week.
- 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.
Read the 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.
- Conditions
- Iron Deficiency Anemia in Pregnancy
- Being tested
- Intravenous Ferric Carboxymaltose (FCM), Iron Sucrose (IS) Infusion
- 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
- Medical subject headings
- Anemia, Iron-Deficiency, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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) InfusionDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (FCM) : Ferric Carboxymaltose | Experimental | 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. Receives: Drug: Intravenous Ferric Carboxymaltose (FCM) |
| Group B : ( IS )Iron Sucrose Arm | Experimental | 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 Receives: Drug: Iron Sucrose (IS) Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 4 weeks post-infusion
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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=
Measured: 1 month after completion of the full iron dose regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anemia in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHAHLA KAREEM ALALAF, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721519
- Sponsor's protocol ID
- HMU 5
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No