Manirakiza 2021.
Study characteristics | ||
Methods | A multicentre, open‐label, superiority RCT comparing SP for IPTp with cotrimoxazole under real‐life conditions | |
Participants | 193 HIV‐positive pregnant women at 4 maternity clinics in Bangui, Central African Republic Inclusion criteria
Exclusion criteria
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Interventions | Cotrimoxazole (administered once daily) vs SP forIPTp (3 curative doses spaced one month apart) | |
Outcomes | The primary outcome was placental parasitaemia. Secondary outcomes were maternal anaemia, incidence of malaria episodes during pregnancy, cord blood parasitaemia, prematurity, low birth weight, spontaneous abortions, stillbirths, neonatal mortality, occurrence of drug‐related adverse events, and mother‐to‐child transmission of HIV. | |
Notes | All pregnant women received an insecticide‐treated net. All participants received a preventive ART to reduce HIV mother‐to‐child transmission: (i) zidovudine from week 16 of amenorrhoea; (ii) zidovudine, lamivudine and nevirapine during labour and delivery, and (iii) zidovudine and lamivudine for 7 days after delivery. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization of women was centralized and stratified on maternity clinic and gravidity (primigravidae vs multigravidae). Randomization lists were generated using a 1:1 ratio. |
Allocation concealment (selection bias) | Low risk | “Once a pregnant woman is confirmed to be eligible for the study, the field investigator will telephone the coordination staff at the Institut Pasteur of Bangui to indicate the gravid rank, and the site staff will assign women to a treatment arm according to the randomization list, respecting the chronological order of inclusion.” |
Blinding of participants and personnel (performance bias) All outcomes | High risk | This study was an open‐label clinical trial. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | This study was an open‐label clinical trial. |
Incomplete outcome data (attrition bias) All outcomes | High risk | The primary end point was documented in only 112 of 193 randomized women. A substantial number of pregnant women in the study delivered at home during an imposed curfew or were lost to follow‐up. This limitation occurred primarily because of a worsening sociopolitical crisis in the Central African Republic. |
Selective reporting (reporting bias) | Low risk | Not observed |
Other bias | Low risk | Not observed |