Dommisse 1983.
Methods | RCT, 2‐arm trial with individual randomisation. | |
Participants | 146 pregnant women with less than 20 weeks of gestation who had not received iron therapy recently attending the Peninsula Maternity Service, Department of Obstetrics and Gynecology, University of Cape Town, Groote Schuur Hospital, South Africa. | |
Interventions | Participants were randomly allocated to receive either a multivitamin tablet twice a day or a multivitamin tablet in conjunction with a standard ferrous sulphate tablet twice a day providing a total of 120 mg of elemental iron daily. Setting and health worker cadre: the intervention was performed by obstetricians and professional staff at the Peninsula Maternity Service of the Department of Obstetrics and Gynecology of the University of Cape Town and Groote Schuur Hospital in Cape Town, South Africa. |
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Outcomes | Hb, PCV, MCV, MCHC, serum iron, transferrin, red cell folate, ferritin, iron storage depletion at baseline and at 36 weeks' gestation, compliance. | |
Notes | Mean Hb and other outcomes at term were reported, but no SDs were provided. We have therefore not been able to include data from this trial in the review. Gestational age at start of supplementation: early gestational age (supplementation started before 20 weeks' gestation). Anaemic status at start of supplementation: mixed/not specified. Daily iron dose: higher daily dose (60 mg or more elemental iron). Iron release formulation: normal release preparation/not specified. Iron compound: ferrous sulphate. Malaria setting: yes. As of 2011: Malaria risk due predominantly to P. falciparum exists throughout the year in the low altitude areas of Mpumalanga Province (including the Kruger National Park), Northern Province and north‐eastern KwaZulu‐Natal as far south as the Tugela River. Risk is highest from October to May inclusive. Resistance to chloroquine and sulphadoxine–pyrimethamine reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomly allocated." |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding mentioned. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding but all outcomes were laboratory measures. The large number of women excluded after randomisation is likely to have affected results and compliance (assessed by unblinded staff) may have been systematically different in the 2 arms of the trial. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 146 were randomised but when compliance was assessed as poor or doubtful, the participant was excluded from the trial. 21 patients were excluded for poor or doubtful compliance and 20 patients delivered before 36th weeks' gestation. Only 105 completed the trial. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | Unclear risk | No other bias apparent. |