Menéndez 2008.
Study characteristics | ||
Methods | Randomized, double‐blind, placebo‐controlled trial | |
Participants | 207 HIV‐positive pregnant women in Southern Mozambique Inclusion criteria
Exclusion criteria
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Interventions | 2 doses of SP for IPTp delivered through antenatal clinics vs placebo | |
Outcomes | The primary study outcome was low birth weight. Secondary outcomes were maternal peripheral parasitaemia at delivery, placental malaria, haemoglobin level at delivery, maternal anaemia, maternal viral load at delivery, prematurity rate, mean birth weight, and mother‐to‐child transmission of HIV. Of note, this trial also assessed safety outcomes for the overall sample of HIV‐positive and uninfected women. We requested disaggregated data by HIV‐status, but safety outcomes could not be retrieved for the subgroup of HIV‐positive women. |
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Notes | All participants received an LLIN. All participants were given nevirapine prophylaxis. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A computer‐generated sequential list contained the study numbers linked to treatment identification letters, randomly ordered in blocks of 10. After written informed consent was obtained, the lowest available study number was assigned. |
Allocation concealment (selection bias) | Unclear risk | Allocation was stored in a computer‐generated list, but there is no information about where this list was kept or who had access to it. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | This study was a double‐blind, placebo‐controlled trial. Tablets of SP or placebo, identical in shape and colour, were stored in 10 bottles labelled only with a single treatment identification letter. Women were randomized to receive 3 tablets of SP (1500 mg sulphadoxine/75 mg pyrimetamine) or placebo. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | As nurses and doctors were blinded, and the principal outcome of the study was low birth weight, we judged the study to have a low risk of detection bias. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The paper does not explain why a few children did not have data on weight, or whether baseline characteristics were balanced among those who were weighed and those who were not. |
Selective reporting (reporting bias) | Low risk | Not observed |
Other bias | Low risk | Not observed |