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Inj. Ferric Carboxymaltose (FCM) Vs Iron Isomaltoside (IIM) in treatment of iron deficiency anemia in Pregnancy (Antenatal)

Inj. Ferric Carboxymaltose (FCM) Vs Iron Isomaltoside (IIM) in anemia in Pregnancy (Antenatal)- A Randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025180
Enrollment
140
Registered
2020-05-14
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O20-O29- Other maternal disorders predominantly related to pregnancy

Interventions

Intervention1: Injection Iron Isomaltoside: Injection Iron Isomaltoside is a parenteral iron formulation given to correct iron deficiency anemia. It is given intravenously according to the iron defici

Sponsors

Bhawna Garg
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Antepartum women whose Hemoglobin is in range of 7 to 10.9 gram per decilitre Women in second trimester of pregnancy (14- to 22 weeks)

Exclusion criteria

Exclusion criteria: Women not willing to participate Women with less than 14 weeks of gestation Women in labor Known case of Thalassemia or Megaloblastic anemia Women who have a history or known allergy to parenteral iron infusion. Women with normal serum ferritin levels history of any liver disease history of any Autoimmune disease

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy (rise in Haemoglobin) of Injection Iron Isomaltoside in comparison to Injection Ferric Carboxymaltose in treating Iron deficiency anemia in pregnancy.Timepoint: at 26 to 30 weeks of gestation

Secondary

MeasureTime frame
To investigate the safety in terms of local and systemic reactions and tolerability of injection Iron Isomaltoside in comparison with injection Ferric CarboxyMaltoseTimepoint: immediately during drug administration till the period of 30 minutes

Countries

India

Contacts

Public ContactBhawna Garg

Jawaharlal Nehru Medical College

mbbellad@hotmail.com9448124893

Outcome results

None listed

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