A study of Ferric Carboxymaltose in Pregnant women lacking iron.

Completed

• Conditions: Other maternal disorders predominantly related to pregnancy,

• Registration Number: CTRI/2021/01/030515
• Lead Sponsor: Pushpam Maternity Hospital Sonography Centre

Brief Summary

This is a prospective, non-interventional, post-marketing, observational, investigator initiated study with involvement of pregnant women with iron deficiency anemia and clinically requiring ferric carboxymaltose injection as per approved prescribing information with objective to evaluate the efficacy and safety of FCM for the treatment of moderate to severe iron deficiency anemia in pregnancy.  Patients with IDA fulfilling the inclusion/exclusion criteria will be enrolled into the study. Those willing to participate and provide their health record for the purpose of study will be explained about the study through Patient Information Sheet and then asked to sign the Informed Consent Form. A unique allotment number will be given to all the enrolled patients to maintain his/her confidentiality. Data will be collected by the investigator as per the case report form (CRF) in hard copy. Patient’s demographic characteristics, significant medical history, treatment details and concomitant medications details will be recorded. This study would be of 6 weeks duration.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-18
• Last Update Posted: 2022-04-05
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Pregnant women more than 18 years of age visiting to department of Obstetrics and Gynecology of gestational age between 16-36 weeks.
• Pregnant women with hemoglobin (Hb) level more than 6 and less than 10 g/dl.
• 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.

Exclusion Criteria

• Any other type of anemia other than Iron Deficiency anemia 2.
• Evidence of iron overload conditions (e.g. hemochromatosis / hemosiderosis).
• 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.
• 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.

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 deficiency anemia in pregnancy.	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.	2. To assess improvement in fatigue.

Trial Locations

Locations (1)

Pushpam Maternity Hospital and Sonography Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Pushpam Maternity Hospital and Sonography Centre

🇮🇳Ahmadabad, GUJARAT, India

Dr Mahesh Gupta

Principal investigator

9426499922

pushpamgynec@yahoo.com