Anaemia

Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Women

NCT01131624 | PHASE 3 | INTERVENTIONAL

The purpose of this study is to look at how well Ferric Carboxymaltose, an intravenous iron therapy (iron that is infused directly into your body through a vein), compares with ferrous sulphate capsules taken by mouth in the treatment of iron deficiency anaemia during pregnancy.

20 Sites

252 Participants

Recruiting

18 Years to 70 Years

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SUBMIT

The Northern Hospital

Epping,Victoria,Australia,3076

Vivantes Klinikum Neuklln, Klinikum fr Geburtsmedizin

Berlin,Germany,12351

Klinik Fr Frauenheilkunde und Geburtshilfe Universittsklinikum Marburg

Marburg,Germany,35043

Perinatalzentrum, Klinikum Innenstadt LMU

München,Germany,80337

Kvinnokliniken, Falu lasarett

Falun,Sweden,SE-791

Kvinnokliniken, University Hospital

Lund,Sweden,SE-221

Kvinnokliniken, Karolinska University Hospital

Stockholm,Sweden,17176

Karolinska Universitetssjukhuset Huddinge, Centrum fr fostermedicin KK

Stockholm,Sweden,SE-141

University Hospital, Dept of obstetrics and gynecology Uppsala

Uppsala,Sweden,SE-751

Universittsspital Basel, Geburtshilfe und Schwangerschaftsmedizin Frauenklinik

Basel,Switzerland,4031

Inselspital, Department of Obstetrics and Gynecology

Bern,Switzerland,3010

Humboldtstrasse

Bern,Switzerland,3013

HUG, Dpartement de GyncologieObsttrique

Genève,Switzerland,1211

CHUV, Dpartement de GyncologieObsttrique

Lausanne,Switzerland,1011

OR Lugano, sede Ospedale Civico, Clinica ginecologia ostetricia

Lugano,Switzerland,6900

Universittsspital Zrich, Departement Frauenheilkunde

Zürich,Switzerland,8091

Cukurova University Hospital

Adana,Turkey,01330

Istanbul Uni. Ist. Med. Faculty

Istanbul,Turkey,34093

Zeynep Kamil Hospital, Arakiyeci Haci Mehmet Mahallesi.

Istanbul,Turkey,34668

Dr. Kutfi Kirdar Kartal Research and Education Hospital

Istanbul,Turkey,34890

Study Eligibility Criteria

Inclusion Criteria

* Pregnant women aged ≥18, gestational week ≥20, ≤33 at baseline visit with normal antenatal screening test results.
* Iron deficiency anaemia defined as Hb concentration ≥8 g/dl and ≤10.4 g/dL and serum ferritin ≤20 mcg/L at screening.
* Demonstrated the ability to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments. Patients (or their representative) must provide written informed consent for their participation in the study.

Exclusion Criteria

* Blood transfusion, erythropoietin treatment, parenteral iron or oral iron treatment (1 month prior to screening) or anticipated need for a blood transfusion during the study.
* Anaemia not caused by iron deficiency (e.g., aplastic, megaloblastic or haemolytic anaemia) or related to acute or ongoing, haemoglobinopathies, rheumatic and other chronic diseases, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects and drug induced anaemia.
* Acute or chronic infection, clinically relevant active inflammatory disease (C-reactive protein \>10 mg/dl or outside reference range), any acute infection at screening.
* Pre-eclampsia.
* Multiple pregnancy.
* Evidence on any significant abnormalities on anomaly ultrasound.
* Haemochromatosis or other iron storage disorders.
* Folate deficiency (S-folate \<4.5 nmol/L) at screening.
* Vitamin B12 deficiency (S-cobalamin \<145 pmol/L) at screening.
* Serious medical condition, uncontrolled systemic disease or any other medical condition that, in the judgment of the Investigator, prohibits the patient from entering or potentially completing the study.
* Known chronic renal failure (defined as creatinine clearance \<30 mL/min calculated by Cockcroft-Gault or modification of diet in renal disease formula).
* Severe cardiovascular diseases.
* Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection.
* Inability to fully comprehend and/or perform study procedures in the Investigator's opinion
* History of endocrine disorders
* Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia
* Recent significant bleeding/surgery (within the 3 months prior to screening).
* Chronic/acute hepatic disorder or elevating of liver enzymes (aspartate aminotransferase, alanine aminotransferase) over 2 times above the upper normal limit at screening.
* Participation in any other interventional study since estimated conception and throughout study participation.
* Known hypersensitivity to FCM or other IV iron preparations.

Additional Studies

Additional studies can be found at ClinicalTrials.gov