Guerra 2012.

Methods	Single‐centre, comparative, open‐label, randomised trial, conducted in Spain between March 1 and May 31, 2008. ITT analysis. Follow‐up period was 6 weeks.
Participants	180 puerperal women were screened. 13 women were randomised into 2 groups: 6 women to intervention group A all of whom completed the trial; 7 women to comparator group B, 5 of whom completed the trial. Socioeconomic conditions were not described. Inclusion criteria: age > 18 years, Hb 70 to 100 g/L, and ferritin > 15 µg/L at 24 hours postpartum. Exclusion criteria: iron intolerance, anaemia not caused by iron deficiency, peripartum blood transfusion, severe asthma and atopy, thromboembolism, alcohol or drug abuse, hepatitis B, C or HIV, infection, renal or hepatic dysfunction, no consent.
Interventions	Intervention referred to IV iron sucrose (Venofer ®). Intervention group A: IV Iron sucrose (Venofer ®) 200 mg on day 2 and 4 after delivery. Total iron dose was 400 mg. Comparator group B: oral ferrous sulphate (Tardyferon®) containing 200 mg twice daily before meals for 42 days. Total dose of non‐elemental iron was 16,800 mg.
Outcomes	No preplanned outcomes. The aim of the study was to compare efficacy and safety between IV and oral iron treatment. Maternal mortality, infections, compliance to treatment and adverse events during treatment were registered.
Notes	Source of funding not stated. Authors declare no conflict of interest. Trial authors provided unpublished information and corrections to the published text on request. They reported an error in table 2 on page 193, where the values for group A and B are reversed. Table 3 is correct. The article is published in Spanish.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	System based on random distribution of envelopes in 1:1 ratio.
Allocation concealment (selection bias)	Low risk	Sealed envelopes.
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	Unclear risk	2 out of 7 in the comparator group dropped out. Although, the authors state that dropout was unrelated to treatment, it is not specified what the exact reasons were. It is therefore not possible to assess if the dropouts were in fact not related to the trial.
Selective reporting (reporting bias)	Unclear risk	No preplanned outcome measures stated.
Other bias	Low risk	None known.