González 2014.
Study characteristics | ||
Methods | An individually‐randomized, double‐blind, placebo‐controlled, multicentre efficacy trial | |
Participants | 1071 HIV‐positive pregnant women receiving cotrimoxazole prophylaxis in selected antenatal care clinics in Tanzania, Mozambique, and Kenya Inclusion criteria
Exclusion criteria
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Interventions | Cotrimoxazole plus mefloquine‐IPTp vs cotrimoxazole plus placebo | |
Outcomes | The primary outcome of this study was maternal peripheral parasitaemia at delivery. Secondary outcomes included prevalence of placental Plasmodium falciparum infection, maternal anaemia, maternal viral load at delivery, cord blood parasitaemia, prevalence of low birth weight, prematurity rate, SAEs during pregancy, drug‐related adverse events, and mother‐to‐child transmission of HIV. | |
Notes | All participants received an LLIN. All participants received antiretroviral drugs for prevention of mother‐to‐child HIV transmission according to national guidelines. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The allocation of the participants to the study arms was done centrally by block randomization (block size of 6) stratified by country. |
Allocation concealment (selection bias) | Low risk | The Pharmacy Department of the Hospital Clinic in Barcelona produced and safeguarded the computer‐generated randomization list for each recruiting site until unblinding, and carried out the masking, labelling, and packaging of all study interventional drugs. Study number allocation for each participant was concealed in opaque sealed envelopes that were sequentially numbered and opened only after recruitment by study health personnel. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study participants were assigned a unique study number linked to the allocated treatment group. Investigators, laboratory staff, care providers, and study participants were blinded to intervention throughout the study. The placebo tablets were identical to mefloquine tablets in shape and colour. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Study participants were assigned a unique study number linked to the allocated treatment group. Investigators, laboratory staff, care providers, and study participants were blinded to intervention throughout the study. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All excluded participants, at each stage of the trial, are counted in the flow chart (both ITT and ATP cohorts). All main outcomes for both endpoints are correctly reported in the article. Only infant data are missing (reported in another article with a different objective). |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported. |
Other bias | Low risk | Not observed |