Clinical trial NCT06911034: Ferric Carboxymaltose Versus Iron Sucrose for Treating Anemia in Pregnant Women
Official title: Comparison of Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anemia in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iron Deficiency Anemia (IDA)
Pregnancy
Keywords: Iron deficiency anemia
Pregnancy
Ferric carboxymaltose
Iron sucrose
Lead sponsor: CMH Multan Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2025-04-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 28-34 weeks of gestation
* Iron deficiency anemia (IDA): IDA will be labelled if Hemoglobin is \<10 gm% and serum Ferritin \< 30 ng/ml.

Exclusion Criteria:

* Hepatitis (serum transaminases more than 1.5 times the upper limit of normal) and HIV infection
* serum creatinine level of more than 2.0 mg/dL
* history of allergic reaction to intravenous iron infusion

Primary outcomes:
measure: Change in hemoglobin
timeFrame: After three weeks of completing parenteral iron therapy
Secondary outcomes:
measure: Ferritin levels
timeFrame: Three weeks after completion of parenteral iron therapy
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Cmh Multan Institute of Medical Sciences
state: Punjab
Study officials:
affiliation: CMH Multan Institute of Medical Sciences
name: Nidda Ya Consultant, FCPS
role: STUDY_CHAIR
References:
citation: Bharadwaj MK, Patrikar S, Singh Y. Comparative analysis of injection ferric carboxymaltose vs iron sucrose for treatment of iron-deficiency anemia in pregnancy: systematic review and meta-analysis. J South Asian Fed Obstet Gynaecol. 2023;15(5):629-36.
citation: Comparison of ferric carboxymaltose and iron sucrose for treatment of iron deficiency anemia in pregnancy at tertiary care centre, Western India. Int J Reprod Contracept Obstet Gynecol. 2023;12(6):1844-8.
citation: Jose A, Mahey R, Sharma JB, Bhatla N, Saxena R, Kalaivani M, Kriplani A. Comparison of ferric Carboxymaltose and iron sucrose complex for treatment of iron deficiency anemia in pregnancy- randomised controlled trial. BMC Pregnancy Childbirth. 2019 Feb 4;19(1):54. doi: 10.1186/s12884-019-2200-3.