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â??Comparison of efficacy and safety of intravenous injection of the drug ferric carboxymaltose vs iron sucrose in the treatment of iron deficiency anaemia during pregnancy â?? A randomized controlled trialâ??

â??Comparison of efficacy and safety of intravenous ferric carboxymaltose vs iron sucrose in the treatment of antepartum iron deficiency anaemia â?? A randomized controlled trialâ??

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/01/004369
Enrollment
230
Registered
2014-01-30
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: null- iron deficiency anaemia in pregnancy

Interventions

Intervention1: iron carboxymaltose: Required Dose is calculated using the formula : (Hb deficit x 2.4 x Wt in kg) Route of administration : IV parentral iron infusion with iron carboxymaltose 500mg

Sponsors

KLE Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Antepartum women whose haemoglobin is in the range of 7 to 10 gm/dl

Exclusion criteria

Exclusion criteria: • women not willing to participate • women in labor • serious medical complications • women who have a history or known allergic to parentral iron infusion

Design outcomes

Primary

MeasureTime frame
The mean rise in haemoglobin at the end of 6 weeks is an important parameter to evaluate the efficacy of the therapy.Timepoint: The mean rise in haemoglobin at the end of 6 weeks is an important parameter to evaluate the efficacy of the therapy.

Secondary

MeasureTime frame
To investigate the safety in terms of local and systemic reactions and tolerability of iron carboxymaltose compared with ferric sucrose.Timepoint: To investigate the safety in terms of local and systemic reactions and tolerability of iron carboxymaltose compared with ferric sucrose.

Countries

India

Contacts

Public ContactDr M C Metgud

JNMC , KLE University

metm@rediffmail.com9448527667

Outcome results

None listed

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