Breymann 2000.
Methods | Single‐centre, randomised, controlled trial, conducted in Switzerland. ITT analysis. Follow‐up was 14 days. | |
Participants | 60 anaemic puerperal women (socioeconomic conditions not described) randomised into 3 groups of 20. No women dropped out. Inclusion criteria: postpartum Hb < 100 g/L 24 to 72 hours postpartum. Exclusion criteria: anaemia during pregnancy peripartum blood transfusion, anaemia from causes other than blood loss, history of thromboembolism, signs of infection, history of seizures, alcohol and/or drug abuse, renal or hepatic dysfunction, previous myelosuppressive medication, haemosiderosis, history of iron intolerance, and rheumatoid polyarthritis. |
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Interventions | Intervention referred to rhEPO (group 1).
Group 1: IV rhEPO (Eprex®) 300 U/kg daily for 4 days + IV iron sucrose (Venofer®) 200 mg daily for 2 days, followed by oral treatment: tablet (Gynotardiferon ®, Robapharm) containing 80 mg elemental iron and folic acid 0.35 mg daily for 10 days.
Total rhEPO dose depended on weight, 84,000 U for a person weighing 70 kg. Total elemental iron dose was 1200 mg.
Group 2: IV rhEPO placebo (identical administration of physiological saline) + IV Iron sucrose (Venofer®) 200 mg daily for 2 days, followed by oral treatment: tablet iron sulphate (Gynotardiferon ®, Robapharm) containing 80 mg elemental iron and folic acid 0.35 mg daily for 10 days on an empty stomach. Total elemental iron dose was 1200 mg. Group 3: oral iron sulphate (Gynotardiferon ®, Robapharm) containing 80 mg elemental iron and folic acid 0.35 mg daily for 14 days. Total elemental iron dose was 1120 mg. |
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Outcomes | No preplanned outcome measures. Incidence and severity of serious or unusual adverse events were recorded. Information on maternal mortality was extrapolated from the numbers of blood tests. | |
Notes | Financial support from the University of Zurich. Authors did not provide additional information on request. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No method described. |
Allocation concealment (selection bias) | Low risk | Sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Low risk for groups 1 and 2 (EPO and placebo), where the patients appear to have been blinded to what drug they received, but high in oral group. High risk for subjective outcomes such as adverse events. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Oral group was not blinded. High risk for most outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts. However, the number of screened and excluded patients prior to randomisation was not reported. |
Selective reporting (reporting bias) | Unclear risk | No preplanned outcome measures mentioned. Data on adverse events were not group specific. |
Other bias | Low risk | None known. |