Seid 2008.

Methods	Multicentre, open‐label, randomised controlled trial, conducted from May 9, 2006 to December 27, 2006 in 28 centres in USA. Participants were stratified based on Hb, ferritin levels, and mode of delivery. ITT analyses. Follow‐up was 6 weeks.
Participants	291 anaemic puerperal women were randomised to 2 groups: 143 to the intervention group,where 138 competed the study, modified ITT population was 139 (72.7% were Caucasian, 10.8% Hispanic, 15.8% African American, 0% Asian, 0.7% other); 148 to comparator group,where, 144 competed the study, modified ITT population was 147 (65.3% were Caucasian, 13.6% Hispanic, 18.4% African American, 2% Asian, 0.7% other). Socioeconomic conditions were not described, study population were of mixed ethnic origin. Inclusion criteria: healthy women, Hb < 100 g/L 10 days or less postpartum on 2 or more laboratory tests conducted at least 12 hours apart. Exclusion criteria: estimated blood loss > 1 litre 24 hours prior to randomisation, history of anaemia other than iron deficiency anaemia or peripartum bleeding, current treatment with myelosuppressive therapy or asthma therapy, recent blood transfusions, or EPO treatment within 3 months prior to screening.
Interventions	Intervention referred IV ferric carboxymaltose. Intervention: IV ferric carboxymaltose (brand unknown) given weekly until individual calculated cumulative dose was reached or a maximum of 2500 mg was administered. The maximum single weekly dose was 15 mg/kg, not to exceed 1000 mg per dose. Comparator: oral ferrous sulphate 325 mg (65 mg elemental iron) 3 times daily for 6 weeks. Total dose of elemental iron was 8190 mg. Total dose of non‐elemental iron was 40,950 mg.
Outcomes	Preplanned outcomes were laboratory values and adverse events. Adverse events for participants who were randomised to ferric carboxymaltose and withdrew from the study early were reported for 28 days after the last treatment.
Notes	Trial funded by research grants from American Regent, Inc. Authors provided additional information on request.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Centralised computer randomisation system.
Allocation concealment (selection bias)	Unclear risk	No method described.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label trial. High risk for subjective outcomes such as adverse events.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label trial. High risk for most outcomes.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low dropout rate, detailed flowchart which accounts for all dropouts. However, reason for voluntary dropouts was not stated and the number of screened and excluded patients prior to randomisation was not reported.
Selective reporting (reporting bias)	High risk	Intended outcome measures reported. However, maternal mortality was not reported.
Other bias	Low risk	None known.