Fleming 1985.
Methods | RCT, 5 arms with individual randomisation. | |
Participants | 200 apparently healthy primigravidae Hausa women living in Zaria, Nigeria and planning to deliver in Zaria, with less than 24 weeks of gestation, who had not taken any antimalarial treatment or iron supplements in current pregnancy. | |
Interventions | Participants were randomly assigned to 1 of 5 groups:
group 1: received no active treatment;
group 2: received chloroquine 600 mg base once, followed by proguanil 100 mg per day;
group 3 received in addition to chloroquine and proguanil, 60 mg elemental iron daily;
group 4 received in addition to chloroquine and proguanil, 1000 μg (1 mg) of folic acid daily;
group 5: in addition to chloroquine and proguanil received 60 mg of elemental iron and 1000 μg (1 mg) of folic acid daily. Setting and health worker cadre: the intervention was performed by an obstetrician working with a Hausa‐speaking social worker in Zaria. |
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Outcomes | Full blood count, malarial parasites, serum and red cell folate, at first attendance, 28 week and 36 weeks gestational age, at delivery, and at 6 weeks postpartum, serum vitamin B12 at first attendance and at 36 weeks gestational age, Hb electrophoresis and fetal microscopy once, and bone marrow at delivery, clinical malaria. | |
Notes | Relevant groups are: group 3 vs group 2 for comparison 2: daily oral supplementation with iron alone vs no treatment/placebo. group 4 vs group 5 for comparison 4: daily oral iron + folic acid supplementation vs daily oral folic acid alone (without iron) supplementation. Results were not reported separately for each randomised group and we have been unable to include data from this trial in the review. Gestational age at start of supplementation: mixed gestational age (up to 24 weeks' gestation). Anaemic status at start of supplementation: mixed/unspecified anaemia status. Daily iron dose: higher daily dose (60 mg elemental iron). Iron release formulation: normal release preparation/unspecified. Iron compound: not clear. Malaria setting: yes. Described as a malaria endemic area: 28% of P falciparum in the sample and 40% of those anaemic. As of 2011: Malaria risk due predominantly to P. falciparum exists throughout the year in the whole country. 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) | Low risk | Random numbers table. |
Allocation concealment (selection bias) | Low risk | Treatment allocation code; "Neither the researchers nor the patients were aware of the treatment allocated until after the completion of the study". |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and researchers blinded. Placebos were provided which were packaged so that they "could not be distinguished by sight". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Laboratory outcomes. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Women who were excluded because they developed anaemia or "defaulted"; were replaced. Further loss to follow‐up occurred during the trial; it was not clear how many women were followed up at each data collection point. 89 out of 200 women randomised delivered in the hospital and no complete, clear data could be extracted for the outcomes of interest in this review. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | Unclear risk | No other bias apparent. |