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Comparison of injection Iron Isomaltoside with injection Iron Sucrose for treatment of iron deficiency anaemia in pregnancy

Comparison of injection Iron Isomaltoside with injection Iron Sucrose for treatment of iron deficiency anaemia in pregnancy - A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079458
Enrollment
168
Registered
2025-01-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: O990- Anemia complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: Injection Iron Isomaltoside: The iron isomaltoside 1000 particle is made up of iron and a carbohydrate component, where the iron is securely held within a matrix composed of iron (III)

Sponsors

Rohilkhand Medical College and Hospital, Bareilly
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women at gestation less than 36 weeks with haemoglobin between 7-10 g/dl and MCV less than 80 fl.

Exclusion criteria

Exclusion criteria: Pregnant women at gestation more than or equal to 36 weeks with anaemia due to causes other than iron deficiency. History of intolerance to parenteral iron. History of multiple allergies.

Design outcomes

Primary

MeasureTime frame
To determine efficacy of injection iron isomaltoside and injection iron sucrose. To determine adverse effects of injection iron isomaltoside. To compare injection iron isomaltoside and injection iron sucrose.Timepoint: Outcome will be assessed at baseline, which is before intervention, and after 4 weeks of infusion.

Secondary

MeasureTime frame
Changes in haemoglobin and MCV.Timepoint: Follow up after 4 weeks.

Countries

India

Contacts

Public ContactDr Shobha Mukherjee

Rohilkhand Medical College and Hospital

sanchitakochhar@gmail.com7898919998

Outcome results

None listed

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