A study of Ferric carboxymaltose in pregnant women lacking iro

Phase 4

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

Registration Number: CTRI/2021/10/037065

Lead Sponsor: Global Rainbow Healthcare

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Pregnant women ready to give informed consent for participation in study.

2. Pregnant women more than 18 years of age visiting to department of Obstetrics and Gynecology of gestational age between 16-36 weeks.

3. Pregnant women with hemoglobin (Hb) level more than 6 and less than 10 g/dl.

4. Pregnant women with serum ferritin level less than 50 Ã?Âµg/L

5. Pregnant women with poor compliance to oral iron or oral iron therapy not tolerable or oral iron therapy is inappropriate based on clinical judgment of investigator.

Exclusion Criteria

1. Any other type of anemia other than iron deficiency anemia

2. Evidence of iron overload conditions (e.g. hemochromatosis / hemosiderosis).

3. Prior history of allergic reaction to IV iron

4. Significant cardiovascular disease (including myocardial infarction during the 6 months prior to study inclusion, congestive heart failure NYHA Class III or IV and poorly controlled hypertension)

5. Uncontrolled endocrinological or metabolic disorders including uncontrolled

hyperparathyroidism.

6. Presence of any active infection

7. Known case of malignancy

8. Presence of active liver disease / HBV or HCV infection, HIV infection / AIDS, asthma, or rheumatoid arthritis

9. Treatment with IV Iron preparations or any investigational drug within 4 weeks prior to study enrollment

10. Any condition that, in the opinion of the investigator, does not justify the patientÃ¢â?¬•s inclusion in the study.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in hemoglobin (g/dL)Timepoint: At baseline, 4 weeks and 6 weeks

Secondary Outcome Measures

Name	Time	Method
Change in serum ferritin levels. <br/ ><br>Change in hematological parameters (PCV, MCV, MCH, MCHC). <br/ ><br>Fatigue measurement by Linear Analogue Scale Assessment. <br/ ><br>Health-related quality of life outcomes measured with the Short Form-36 Health Survey (SF-36). <br/ ><br>Adverse effects during the study <br/ ><br>Timepoint: Change in serum ferritin levels over 6 weeks. <br/ ><br>Change in hematological parameters (PCV, MCV, MCH, MCHC) over 6 weeks. <br/ ><br>Fatigue measurement by Linear Analogue Scale Assessment at week 2, 4 & 6. <br/ ><br>Health-related quality of life outcomes measured with the Short Form-36 Health Survey (SF-36)at week 2, 4 & 6. <br/ ><br>Adverse effects during the study