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

PHASE3CompletedINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

May 31, 2014

Study Completion Date

April 30, 2015

Conditions
Anaemia
Interventions
DRUG

ferrous sulphate

200 mg iron per day in a convenient dosage schedule.

DRUG

Ferinject

1000-1500mg diluted only in sterile 0.9% sodium chloride, The maximum single dose of FCM that can be administered by intravenous infusion is 20 mL (1,000 mg iron) but should not exceed 15 mg of iron per kg of body weight. This means that for subjects with a bw below 66 kg a maximal dose of 500 mg iron per infusion is allowed.

Trial Locations (20)

1011

CHUV, Département de Gynécologie-Obstétrique, Lausanne

1211

HUG, Département de Gynécologie-Obstétrique, Geneva

3010

Inselspital, Department of Obstetrics and Gynecology, Bern

3013

Humboldtstrasse, Bern

3076

The Northern Hospital, Epping

4031

Universitätsspital Basel, Geburtshilfe und Schwangerschaftsmedizin Frauenklinik, Basel

6900

OR Lugano, sede Ospedale Civico, Clinica ginecologia ostetricia, Lugano

8091

Universitätsspital Zürich, Departement Frauenheilkunde, Zurich

12351

Vivantes Klinikum Neukölln, Klinikum für Geburtsmedizin, Berlin

17176

Kvinnokliniken, Karolinska University Hospital, Stockholm

34093

Istanbul Uni. Ist. Med. Faculty, Istanbul

34668

Zeynep Kamil Hospital, Arakiyeci Haci Mehmet Mahallesi., Istanbul

34890

Dr. Kutfi Kirdar Kartal Research and Education Hospital, Istanbul

35043

Klinik Für Frauenheilkunde und Geburtshilfe Universitätsklinikum Marburg, Marburg

80337

Perinatalzentrum, Klinikum Innenstadt LMU, München

SE-791

Kvinnokliniken, Falu lasarett, Falun

SE-221

Kvinnokliniken, University Hospital, Lund

SE-141

Karolinska Universitetssjukhuset Huddinge, Centrum för fostermedicin KK, Stockholm

SE-751

University Hospital, Dept of obstetrics and gynecology Uppsala, Uppsala

01330

Cukurova University Hospital, Adana

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Pierrel Research Europe GmbH

INDUSTRY

lead

Vifor Pharma

INDUSTRY