Not Yet RecruitingNot Applicable

Comparing Two Intravenous Iron Treatments for Anemia in Kurdish Pregnant Women

400 participantsStarted 2026-09-01

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in Hemoglobin (Hb) Levels at 4 Weeks Post-Infusion

Timeframe: Baseline to 4 weeks post-infusion

Trial details

NCT IDNCT07721519

SponsorHawler Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-01

Contact for this trial

SHAHLA KAREEM ALALAF, PROFESSOR

+9647504480711 shahla_alaf@yahoo.com

View on ClinicalTrials.gov More Iron Deficiency Anemia in Pregnancy trials