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Comparing Two Intravenous Iron Treatments for Anemia in Kurdish Pregnant Women

NCT07721519 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-07-23

No results posted yet for this study

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.

Conditions

  • Iron Deficiency Anemia in Pregnancy

Interventions

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/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

DRUG

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.

Sponsors & Collaborators

  • Hawler Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-03-01
Completion
2028-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07721519 on ClinicalTrials.gov