comparison of intravenous iron preparations to treat iron-deficiency anemia in antepartum women

Phase 4

Not yet recruiting

Conditions: Anemia complicating pregnancy, childbirth and the puerperium,

Registration Number: CTRI/2022/07/044023

Brief Summary: Anemia is one of the major health issues worldwide and during pregnancy, it is associated with increased morbidity & mortality of pregnant women and the developing fetus. Anemia in india contributes as cause of 20% maternal death directly and 50% for associated causation. Iron- deficiency anemia is most common type of nutritional deficiency (but manageable) affecting both developed and developing countries. Oral iron supplementation is most effective way of therapy, but parenteral iron is reserved for patients who are either intolerant to oral therapy, non-compliant or having malabsorption from the gut.

Our study compares the efficacy & safety of parenteral ferric carboxy maltose (FCM) vs iron-sucrose complex for treatment of iron deficiency anaemia in pregnant women. The primary objective is to compare the improvement in haematological parameters like hb, red cell indices (MCV, MCHC, RDW, haematocrit) & serum ferritin in both groups and compare the adverse drug reactions. Secondary objective is to study and compare the number of units of drug utilized, duration & cost of therapy.

This prospective Randomized controlled study will be done in the Department of obstetrics & gynaecology, dr. baba Saheb Ambedkar, medical college & hospital (sector 6, Rohini, new Delhi) over a period of 1 year. Pregnant women between 16-34 weeks of gestation and Haemoglobin level 7-9.9 gm/dl who are non-compliant or failed to respond to oral haematinics attending antenatal OPD, emergency OPD & antenatal ward will be enrolled in the study after giving consent and will further be assigned to group A or group B (30 in each) respectively. Total iron dose required will be calculated by using Ganzoniâ€™s formula taking into account the target Haemoglobin post-correction as per WHO which is maximum 11 gm/dl. Group A will receive intravenous ferric carboxymaltose (FCM) and group B will receive intravenous iron- sucrose complex as per the standard dosing regime. Patients will be observed for adverse reactions & side effects till 1 hour after infusion and the same will be documented.

All patients will be followed-up on OPD basis at 2nd and 6th week after completion of treatment with their blood investigations namely haemoglobin, RBC indices (MCV, MCHC, RDW, HCT) and serum ferritin. Data will be entered in MS-EXCEL spreadsheet and will be analysed using SPSS version 21.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 60

Inclusion Criteria

pregnant women between gestation age 16-34 weeks with Hb between 7-9.9 gm/dl and failed oral supplementation therapy of iron.

Exclusion Criteria

pregnant patients with allergy to iron therapy previously, known medical illness such as asthma, thromboembolism, requiring emergency cesarean section and negative consent.
patient who requires blood transfusion for severe anemia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to measure the improvement in hematological parameters such as Hb, RBC indices and serum ferritin between group A and group B	6 weeks

Secondary Outcome Measures

Name	Time	Method
adverse effects and side effects	6 weeks

Trial Locations

Locations (1): dr baba saheb ambedkar medical collge and hospital
🇮🇳
Delhi, DELHI, India
dr baba saheb ambedkar medical collge and hospital
🇮🇳Delhi, DELHI, India
dr sarita mishra
Principal investigator
8896477438
saritamishra565@gmail.com