Menendez 2008 MOZ.
Methods | Trial design: RCT Data collected: August 2003 to April 2005 Length of follow‐up: from recruitment until 8 weeks postpartum Frequency of follow‐up: unclear. Mean number of outpatient visits during pregnancy 1.64 in the SP and 1.83 in the placebo group. Mean number of visits post‐partum 0.69 in the SP group and 0.68 in the placebo group |
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Participants | Parity: all Number: 1030 Inclusion criteria: permanent residents of the CISM trial area with gestational age ≤ 28 weeks Excluded: allergic to sulpha drugs |
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Interventions |
Other: ITNs Administration supervised: yes |
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Outcomes |
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Notes | Location: Mozambique Urban/rural: urban Malaria transmission: perennial malaria transmission with some seasonality Drug resistance: evidence suggests that SP was highly effective in the area during the trial HIV: In the SP group, 26.5% (117/441 women), and in the placebo group, 21.2% (91/429 women). Overall: 23.9% Funding: Fondo de Investigaciones Sanitarias del Instituto de Salud Carlos III (grant number CM03/00125); Banco de Bilbao, Vizcaya, Argentaria Foundation (grant number BBVA 02‐0); Spanish Agency for International Cooperation (AECI) |
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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". |
Allocation concealment (selection bias) | Low risk | "Tablets of SP or placebo... were stored in 10 bottles labelled only with a single treatment identification letter." |
Blinding (performance bias and detection bias) All outcomes | Low risk | SP and placebo tablets "identical in shape and colour". |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | In the SP group 35/515 (6.8%) did not receive 2 doses and birthweight was not measured for 7/501 (1.4%) live births. In the placebo group 29/515 (5.6%) did not receive 2 doses and birthweight was not measured for 7/503 (1.4%) live births. |
Selective reporting (reporting bias) | Low risk | None identified (trial protocol available). |
Other bias | Unclear risk | Data were analysed by ITT analysis whereby all randomized women were included regardless of whether or not they had received the intervention and the number of doses. Women with a multiple delivery (twins or triplets) as well as those who did not receive all three doses were also included in the analysis. |