A prospective randomized, controlled trial of intravenous versus oral iron for moderate iron deficiency anaemia of pregnancy.
BACKGROUND
Iron deficiency anaemia is the most common deficiency disorder in the world, affecting more than one billion people, with pregnant women at particular risk.


OBJECTIVE
We conducted a single site, prospective, nonblinded randomized-controlled trial to compare the efficacy, safety, tolerability and compliance of standard oral daily iron versus intravenous iron.


METHODS
We prospectively screened 2654 pregnant women between March 2007 and January 2009 with a full blood count and iron studies, of which 461 (18%) had moderate IDA. Two hundred women matched for haemoglobin concentration and serum ferritin level were recruited.


METHODS
Patients were randomized to daily oral ferrous sulphate 250 mg (elemental iron 80 mg) with or without a single intravenous iron polymaltose infusion.


RESULTS
Prior to delivery, the intravenous plus oral iron arm was superior to the oral iron only arm as measured by the increase in haemoglobin level (mean of 19.5 g/L vs. 12 g/L; P < 0.001); the increase in mean serum ferritin level (222 microg/L vs. 18 ug/L; P < 0.001); and the percentage of mothers with ferritin levels below 30 microg/L (4.5% vs. 79%; P < 0.001). A single dose of intravenous iron polymaltose was well tolerated without significant side effects.


CONCLUSIONS
Our data indicate that intravenous iron polymaltose is safe and leads to improved efficacy and iron stores compared to oral iron alone in pregnancy-related IDA.
Khalafallah
A
A
Launceston General Hospital (LGH), University of Tasmania, Tasmania, Australia. khalafallah@dhhs.tas.gov.au
Dennis
A
A
Bates
J
J
Bates
G
G
Robertson
I K
IK
Smith
L
L
Ball
M J
MJ
Seaton
D
D
Brain
T
T
Rasko
J E J
JE
D000284:Administration, Oral; D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000188:drug therapy*; D001724:Birth Weight; D004359:Drug Therapy, Combination; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D005293:Ferritins / Q000097:blood; D005296:Ferrous Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D010349:Patient Compliance; D011247:Pregnancy; D011250:Pregnancy Complications, Hematologic / Q000097:blood / Q000188:drug therapy*; D011446:Prospective Studies; D011788:Quality of Life; D055815:Young Adult
D005290:Ferric Compounds; D005296:Ferrous Compounds; D006397:Hematinics; D006454:Hemoglobins; C020748:ferrous sulfate; D005293:Ferritins; C013276:teferrol