Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT06911034
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2025-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ferric Carboxymaltose Versus Iron Sucrose for Treating Anemia in Pregnant Women
Sponsor:
CMH Multan Institute of Medical Sciences
Organization:
Study Overview
Official Title:
Comparison of Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anemia in Pregnant Women
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial aimed to determine whether intravenous ferric carboxymaltose is more useful than iron sucrose for treating anemia in pregnant women.
The main question it aimed to answer was:
Is intravenous ferric carboxymaltose is more useful than iron sucrose for treating iron deficiency anemia in pregnant women.
Sixty pregnant women with iron deficiency anemia were enrolled to one of two intravenous treatments.
* Participants in ferrous carboxymaltose group received a maximum dose of 1000 mg per sitting diluted in 200 ml 0.9% normal saline and administered as an IV infusion over 30 min.
* Participants in iron sucrose group were administered an infusion of 300 mg in 200 ml NS over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week.
The main question it aimed to answer was:
Is intravenous ferric carboxymaltose is more useful than iron sucrose for treating iron deficiency anemia in pregnant women.
Sixty pregnant women with iron deficiency anemia were enrolled to one of two intravenous treatments.
* Participants in ferrous carboxymaltose group received a maximum dose of 1000 mg per sitting diluted in 200 ml 0.9% normal saline and administered as an IV infusion over 30 min.
* Participants in iron sucrose group were administered an infusion of 300 mg in 200 ml NS over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week.
Detailed Description:
The study was conducted after the ethics review committee approval. A total of 60 pregnant women presenting to the department of Obstetrics and Gynecology and fulfilling the eligibility criteria were enrolled in the study after informed consent. Patient's characteristics including age, parity, area of residence, educational status, socioeconomic status and baseline Hb were recorded. All women were administered anthelminthic therapy with tablet mebendazole 100 mg twice daily for three days and given 5 mg Folic acid once daily. Patients were be randomly assigned to group A \& B.
Patients in group A were treated with intravenous ferrous carboxymaltose and group B were given intravenous iron sucrose complex. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again.
Patients in group A were treated with intravenous ferrous carboxymaltose and group B were given intravenous iron sucrose complex. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: