A study of Ferric carboxymaltose in pregnant women lacking iro

Phase 4

Completed

• Conditions: Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

• Registration Number: CTRI/2021/02/030874
• Lead Sponsor: Radhakrishna Multispecialty Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-11
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

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

weeks.

2. Pregnant women with hemoglobin (Hb) level more than 6 and less

than 10 g/dl.

3. Pregnant women not responding to oral Iron or oral iron therapy not tolerable or oral iron therapy is inappropriate based on clinical

judgment of investigator

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

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 patientâ??s inclusion in the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of ferric carboxymaltose (FCM) injection in moderate to severe iron <br/ ><br>deficiency anemia in pregnancy.Timepoint: Mean change in hemoglobin from baseline to week 6.

Secondary Outcome Measures

Name	Time	Method
1. To assess the safety of ferric carboxymaltose (FCM) injection in moderate to severe iron deficiency anemia in pregnancy <br/ ><br>2. To assess improvement in fatigueTimepoint: 1 Change in serum ferritin levels over 6 week <br/ ><br>2 Change in hematological parameters (PCV, MCV, MCH, MCHC) over 6 week <br/ ><br>3 Fatigue measurement by Linear Analogue Scale Assessment at week 2, 4 & 6 <br/ ><br>4 Adverse effects during the study