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Comparison of two inject able iron preparations for treatment of iron deficiency anemia in pregnancy

Comparison of efficacy , safety & tolerability of intravenous ferric carboxymaltose with intravenous iron sucrose for treatment of iron deficiency anemia in pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017553
Enrollment
100
Registered
2019-02-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O251- Malnutrition in pregnancy

Interventions

Intervention1: Ferric carboxymaltose: as per calculated iron dose will be administered maximum 1000 mg at a time as IV infusion in 250 ml of normal saline over 30 minutes Control Intervention1: Iron

Sponsors

Department of Obstetrics and Gynecology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Antenatal women with (20-34 weeks ) gestation with diagnosed iron deficiency anemia of varying severity(Hb 6-9.9g/dl) Singleton pregnancy

Exclusion criteria

Exclusion criteria: Hemodynamic instability or clinically perceived or anticipated need of blood transfusion History of repeated blood transfusions Haemoglobinopathies bleeding diathesis Known history of asthma allergies hypersensitivity reactions eczema History of hypersensitivity reaction to iron preparations Advanced Systemic illnesses involving renal/hepatic /cardiovascular system Conditions associated with iron overload viz thalessemia hemochromatosis

Design outcomes

Primary

MeasureTime frame
Improvement in anemia by hematological assessment at end of 4 weeks after IV Iron supplementation. Incidence of Local ADR /systemic ADRTimepoint: Improvement in anemia by hematological assessment at end of 4 weeks after IV Iron supplementation.

Secondary

MeasureTime frame
Delivery-term/preterm NICU stay in days & reason Birth weight Cord blood hematology Timepoint: After Delivery

Countries

India

Contacts

Public ContactDr Geeta S Wadadekar

Bharati Vidyapeeth Deemed University Medical College Pune

geetsw1393@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026