A study to assess if using IV Ferric Carboxy Maltose (FCM) in Management of Iron Deficiency Anemia (IDA) among pregnant women is better than IV Iron Sucrose in terms of duration of treatment, side effects and cost-effectiveness at sub district health system in Maharashtra
- Conditions
- Iron deficiency anemia, unspecified, (2) ICD-10 Condition: D509||Iron deficiency anemia, unspecified,
- Registration Number
- CTRI/2021/08/036037
- Lead Sponsor
- Department of health research
- Brief Summary
The study is focusing on a very important public health problem “Anemia in Pregnancyâ€. Very recently IV Sucrose was tested for its efficacy among anemic pregnant women1 which showed no difference in pregnancy outcomes due to use of injectable vs oral iron. Till date IV Iron sucrose is the most commonly used injectable iron preparation for treatment of iron deficiency anemia. However use of this iron sucrose mandates the patient to visit the health facility three times on alternate day .This study intends to test the new compound Ferric Carboxy Maltose (FCM) for managing anemia in pregnancy which is given in a bolus single dose and equally efficacious with no adverse effects . A single dose of FCM may have better compliance than multiple doses with IV Iron Sucrose. Although Poshan Abhiyan has suggested this drug in the guidelines, State health department of Maharashtra has not officially introduced it in program at all levels of health care. Hence this study will generate evidence to facilitate program decision making and strengthen the management strategy within district health system.
a]Pregnant women registered for ANC & diagnosed with moderate IDA between 22weeks-32 weeks [after trying standard oral iron] OR diagnosed with severe anemia between 22 weeks to 32 weeks of pregnancy]
b]Not responding to oral iron therapy
c]Enroll for parenteral iron randomly assigned to either IV FCM or IV Iron sucrose
d]Follow up after 4 weeks to check improvement in blood indices
e]Follow-up 6 weeks after delivery to document pregnancy and neonatal
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 280
- Diagnosed with iron deficiency anemia with hemoglobin levels between 5- 9.9gm/dl between 22-32 weeks of gestational age with following criteria Severe anemia with hemoglobin <7 gms anytime between 22-32 weeks Moderate anemia with hemoglobin between 7-9.9 gms during 22-28 weeks not responding to oral iron given for 6 weeks Moderate anemia in last trimester irrespective of previous iron intake.
- Willing to sign an informed consent, deliver at the same site and willing for follow up.
- •Pregnant women with hemoglobin levels below 5gm/dl and above 9.9 gm/dl in the first or second trimester of pregnancy.
- •Pregnant women diagnosed with anemia other than iron deficiency anemia based on peripheral smear examination and red cell indices, picture suggestive of pancytopenia, •Any known cases of hemoglobinopathies or with Pregnancy Induced Hypertension • History of iron overload disorder (Thalassemia, hemochromatosis, hemosiderosis] •Pregnant women with known cardiac, renal, hepatic disease •Pregnant women having associated medical disorders like hypertension, asthma, tuberculosis, heart disease rheumatic or congenital heart disease), heart failure or cardiac decompensation, •history of intravenous iron therapy in the past 6 months or history of repeated blood transfusions •Pregnant women with known OR history of hypersensitivity to ferric carboxy-maltose or iron sucrose •Pregnant women in labor •Blood loss due to hemodynamic instability •History of malignancy, GI bleed, surgery •suspected acute infections (such as upper respiratory tract infections, urinary tract infections, or fever at the time of visit), h/o of rashes and fever during pregnancy to rule rubella).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in Hb, Ferritin, transferrin saturation 1.4weeks 2.6months 2.Adverse events during IV iron administration 1.4weeks 2.6months 3.Compliance to treatment 1.4weeks 2.6months 4.Need for blood transfusions 1.4weeks 2.6months 5.Anemia in mother post-partum at 6 weeks 1.4weeks 2.6months 6.Type of delivery and indications 1.4weeks 2.6months 7.Complications during delivery – PPH, puerperal sepsis, shock etc 1.4weeks 2.6months 8.Live births, still births 1.4weeks 2.6months 9.Birth weight 1.4weeks 2.6months 10.Prolonged hospital stay 1.4weeks 2.6months 11.Need for admission in intensive care unit 1.4weeks 2.6months
- Secondary Outcome Measures
Name Time Method Feasibility and acceptability Costs and Quality of lIfe
Trial Locations
- Locations (2)
Patangshah Cottage Hospital Jawhar
🇮🇳Thane, MAHARASHTRA, India
Sub district Hospital Dahanu
🇮🇳Thane, MAHARASHTRA, India
Patangshah Cottage Hospital Jawhar🇮🇳Thane, MAHARASHTRA, IndiaDr Bharat MahalePrincipal investigator09321216311drbharatmahale@gmail.com