[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648429":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":32,"locations":25,"responsibleParty":43,"collaborators":25,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":25,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":25,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":78,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":25},{"fullName":5,"class":6},"Hawler Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: Intravenous Ferric Carboxymaltose (FCM)",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B : ( IS )Iron Sucrose Arm","Participants assigned to this arm will receive intravenous (IV) iron sucrose (Blogen, 20 mg\u002FmL 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\u002FmL (safely above the manufacturer's 1 mg\u002FmL 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",[18],"Drug: Iron Sucrose (IS) Infusion",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","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\u002FmL, 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",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"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. 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.",[15],[31],"Blogen",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":25,"email":37},"SHAHLA KAREEM ALALAF, PROFESSOR","CONTACT","+9647504480711","shahla_alaf@yahoo.com",{"name":39,"role":35,"phone":40,"phoneExt":41,"email":42},"RAQIB HUSEIN","07504729617","00964","raqib.husei@hmu.edu.krd",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","SHAHLA KAREEM ALALAF","PROFESSOR","100648429","comparing-two-intravenous-iron-treatments-for-anemia-in-kurdish-pregnant-women-100648429",false,"NCT07721519","Comparing Two Intravenous Iron Treatments for Anemia in Kurdish Pregnant Women","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","Inclusion Criteria:\n\n* Parity: All parity levels accepted (Para 0, Para 1, Para 2-4, and Para 5 or more).\n* Pregnancy Stage: Currently in the second or third trimester of pregnancy (greater than 14 weeks gestation).\n* Confirmed Iron Deficiency Anemia (IDA): Documented Hemoglobin (Hb) less than 11 g\u002FdL AND Serum Ferritin less than 30 ng\u002FmL.\n* Medical Indication for Intravenous (IV) Iron: Must meet at least one of the following specific clinical indications:\n\n  1. Intolerance to oral iron therapy (e.g., severe nausea, severe constipation, or gastrointestinal distress).\n  2. Failure to respond to oral iron therapy (defined as a Hemoglobin increase of less than 1 g\u002FdL after 3 weeks of compliant oral intake).\n  3. Late presentation in the third trimester (greater than 34 weeks gestation) requiring rapid correction of anemia.\n  4. Moderate to severe anemia at presentation (defined as Hemoglobin less than 9.0 g\u002FdL).\n\nExclusion Criteria:\n\n* First trimester of pregnancy (less than or equal to 14 weeks gestation).\n* Known hypersensitivity, allergy, or previous severe adverse reaction to intravenous iron formulations or any of their components.\n* Anemia due to causes other than iron deficiency (e.g., vitamin B12 or folate deficiency, hemoglobinopathies, anemia of chronic disease).\n* Active, severe systemic infection.\n* Relevant medical exclusions , such as severe hepatic or renal impairments","FEMALE","18 Years","45 Years",{"count":58,"type":59},400,"ESTIMATED","INTERVENTIONAL",[62],"NA","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:\n\n1. Does FCM lead to a higher increase in hemoglobin (blood iron) levels 4 weeks after treatment compared to IS?\n2. What medical problems or side effects do women experience with each drug?\n3. Does FCM reduce the number of hospital visits and improve women satisfaction?\n\nParticipants will:\n\n1. 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).\n2. 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.\n3. Receive FCM in one or more full doses, or receive IS split into multiple smaller sessions up to 3 times a week.\n4. 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.",[65],"Iron Deficiency Anemia in Pregnancy",[67,68,69,70,71,72,73,74,75,76,77],"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","NOT_YET_RECRUITING","2026-07-18",{"date":81,"type":82},"2026-07-23","ACTUAL",{"date":84,"type":59},"2026-09-01",{"date":86,"type":59},"2028-12-01",{"name":5,"class":6}]