A CLINICAL TRIAL TO STUDY THE EFFECT OF TWO DRUGS, FERRIC-CARBOXY MALTOSE AND IRON SUCROSE COMPLEX FOR TREATMENT OF IRON DEFICIENCY ANEMIA IN PREGNANT WOMEN

Phase 3

Not yet recruiting

Conditions: Anemia complicating pregnancy, childbirth and the puerperium,

Registration Number: CTRI/2023/02/049803

Lead Sponsor: BPS Govt. Medical College for Women, Khanpur kalan

Brief Summary: **Whether parenteral iron therapy in form on ferric carboxymaltose in terms of efficacy, safety and compliance has advantage over iron sucrose complex for treatment of iron deficiency anemia in ante-partum patients?**

Women presenting with iron deficiency anemia and Hb 6-9.9gm % will be randomized based computer generated block randomization technique in group 1 or group 2.

**Group1:**- will be formed by the patients receiving Ferric Carboxymaltose

**Group 2:**- will be formed by the patients receiving iron sucrose complex.

Follow-up visits will be done after 3, 6 and 9 weeks from start of treatment. Primary outcome to note will be change in Hb level from baseline on follow-up visits. Secondary outcomes will be change in RBC indices, RDW, change in serum ferritin levels, change in fatigue levels (LASA to measure improvements in fatigue scores and a 10 point numeric scale to assess the feeling of well-being), safety and side effects of treatment and peri-natal outcome (in terms of time of delivery/ abortion/preterm delivery).

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 220

Inclusion Criteria

Ante-partum women Age between 18 to 35 years.
Hemoglobin between 6-9.9 gm %..
Iron deficiency anemia 24-34 weeks of period of gestation.

Exclusion Criteria

Other than Iron Deficiency Anemia Acute or Chronic Liver diseases HIV 1st Trimester of Pregnancy Serum transaminases > 1.5 times upper limit of normal Serum Creatinine > 2.0 mg/dL History of allergic reaction to intravenous iron infusion Anemia due to other causes Thalassemia patient Iron metabolic disorder Hemosiderosis Hemochromatosis Untreated Pyelonephritis Anaphylactic Reaction.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Hb level from baseline on follow-up visits	baseline, 3 weeks, 6 weeks, 9 weeks

Secondary Outcome Measures

Name	Time	Method
Change in RBC indices, RDW, change in serum ferritin levels,change in fatigue levels, safety and side effects of treatment and peri-natal outcome (in terms of time of delivery/ abortion/preterm delivery)	baseline, 3 weeks, 6 weeks, 9 weeks

Trial Locations

Locations (1): BPS Govt. Medical College for Women, Khanpur kalan
🇮🇳
Sonipat, HARYANA, India
BPS Govt. Medical College for Women, Khanpur kalan
🇮🇳Sonipat, HARYANA, India
Dr Ankit Kumar Dangi
Principal investigator
8295857574
drankitkumardangi@gmail.com