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. 2015 Aug 13;2015(8):CD010861. doi: 10.1002/14651858.CD010861.pub2

Verma 2011.

Methods Multicentre, randomised trial, conducted from January 2010 to July 2010 in 2 Indian centres. ITT analysis. Follow‐up was 30 days.
Participants 150 puerperal anaemic women were randomised to 2 groups of 75. No dropouts were reported.
Socioeconomic conditions were not described in detail. 93.3% of the women came from rural areas.
Inclusion criteria: Hb < 80 g/L 24 hours after delivery.
Exclusion criteria: anaemia from other cause than nutritional deficiency during pregnancy, immuno‐compromised patients, terminal illness, severe cardiac, hepatic, renal, cerebrovascular, malignant, or chronic uncontrolled systemic disease, other serious medical illness, allergy/reaction to iron complex and unwillingness to participate.
Interventions Intervention referred to IV iron sucrose.
 Intervention: IV iron sucrose 200 mg on day 1, 3 and 5. The total iron dose was 600 mg, calculated by following formula: Weight (target Hb–actual Hb) 0.24 + 500 mg.
Comparator: oral ferrous sulphate 200 mg twice daily for 1 month. Total non‐elemental was approximately 12,000 mg.
Outcomes Preplanned outcomes were laboratory values, quality of life, patient satisfaction, impact on cost and hospital stay, blood transfusion frequency, impact on stress, depression and cognitive function, impact on breastfeeding compared to oral iron therapy and recommendation of iron sucrose to postpartum anaemic patients. Compliance and adverse events during treatment were also reported.
Notes Source of funding was not reported.
Two errors were detected in figure 2: first Hb value of oral iron does not correspond to text on page 68 (Haemoglobin Response); last Hb value for oral iron does not correspond to the graph, decimal error.
Total IV iron dose was listed both as a fixed dose of 600 mg, and as a weight‐dependant dose calculated by the Ganzoni formula.
On page 68 the authors state: "In oral group this mean rise of Hb was noted from 9.65 ± 0.88 gm/dl to 11.02 ± 1.02 gm/dl (p < 0.0001) in 30 days (Fig. 2)." These values cannot be found in figure 2.
Adverse events in oral group stated but their rate not given.
Authors did not respond to the request on additional information.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study claimed to be randomised in abstract, but not elsewhere, and no method was described.
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 Unclear risk Unclear description of participants, no mention of dropouts. Number of screened and excluded patients prior to randomisation was not reported.
Selective reporting (reporting bias) High risk No report on the following preplanned outcomes: patient satisfaction, quality of life, cost of treatment, length of hospital stay, use of blood transfusion, impact on stress, depression and cognitive function, lactation. Maternal mortality was not reported.
Other bias High risk Study offers limited amount of information and is difficult to evaluate. Several errors detected.