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Ferric Carboxymaltose Injection in Pregnant women: Retrospective analysis

Efficacy and Safety of Ferric Carboxymaltose Injection in Pregnant women: Retrospective analysis at Indian Real-life Scenario

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/12/029785
Enrollment
200
Registered
2020-12-14
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 Health Condition 2: D508- Other iron deficiency anemias

Interventions

Intervention1: Ferric Carboxy Maltose (FCM): NIL (Retrospective data)

Sponsors

Gupte Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant female patients aged more than 18 years of age who visited to department of Obstetrics and Gynecology in their 2nd and 3rd trimester of gestation. 2. Documented Iron deficiency anemia and received FCM injection. 3. Data for hematological parameters (hemoglobin, serum ferritin) are available at baseline and for minimum at 4 ± 2 weeks. 4. Patients already provided informed consent for future use of their medical records for research.

Exclusion criteria

Exclusion criteria: 1. Any other type of anemia apart from Iron Deficiency anemia 2. Evidence of iron overload conditions (e.g. hemochromatosis / hemosiderosis). 3. Any malignancy. 4. Presence of active liver disease/ HBV or HCV infection, CKD, HIV infection / AIDS, asthma, or rheumatoid arthritis. 5. Any condition that, in the opinion of the investigator, does not justify the patientâ??s inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Mean change in hemoglobin level from baseline to week 4 (± 2)Timepoint: Baseline to week 4 (± 2)

Secondary

MeasureTime frame
1. Change in serum ferritin levels 2. Change in hematological parameters (PCV, MCV, MCH, MCHC) if available 3. Change in serum iron levels, if available 4. Change in TSAT value, if available 5. The adverse events: incidence, severity and relation to FCM will be retrieved and analyzed.Timepoint: Baseline to week 4 (± 2)

Countries

India

Contacts

Public ContactShweta Jangam

Gupte Hospital and Centre for Research in Reproduction

aparnajayu@gmail.com

Outcome results

None listed

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