Ferric Carboxymaltose Injection in Pregnant women:Retrospective analysis

Not Applicable

Completed

• Conditions: Health Condition 1: O251- Malnutrition in pregnancyHealth Condition 2: D508- Other iron deficiency anemias

• Registration Number: CTRI/2020/12/029785
• Lead Sponsor: Gupte Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-01-19
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 168

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in hemoglobin level from baseline to week 4 (± 2)Timepoint: Baseline to week 4 (± 2)

Secondary Outcome Measures

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