Summary of findings 7. Summary of findings table 7.
| Intermittent preventive treatment with SP for pregnant women (parity 0‐1) living in malaria endemic areas: maternal outcomes | |||||
| Patient or population: Pregnant women (parity 0‐1) Settings: Malaria‐endemic areas Intervention: Intermittent preventive treatment with SP (2 doses, 3 doses, or monthly dosing) Control: Placebo or no intervention | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (trials) | Quality of the evidence (GRADE) | |
| Assumed risk | Corresponding risk | ||||
| Control | IPT (SP) | ||||
| Mortality All‐cause death | 7 per 1000 | 8 per 1000 (3 to 20) | RR 1.15 (0.44 to 3.06) | 2097 (2 trials) | ⊕⊝⊝⊝ very low1,2 |
| Severe anaemia During the third trimester | 145 per 1000 | 87 per 1000 (68 to 108) | RR 0.60 (0.47 to 0.75) | 2503 (3 trials) | ⊕⊕⊕⊕ high3,4,5,6 |
| Anaemia | 617 per 1000 | 543 per 1000 (480 to 604) | RR 0.88 (0.81 to 0.96) | 3291 (4 trials) | ⊕⊕⊕⊝ moderate1,6,7,8 |
| Uncomplicated clinical malaria | 9 per 100 | 2 per 100 (0 to 10) | RR 0.24 (0.05 to 1.12) | 174 (1 trial) | ⊕⊝⊝⊝ very low9,10,11 |
| Antenatal parasitaemia | 286 per 1000 | 108 per 1000 (69 to 169) | RR 0.38 (0.24 to 0.59) | 2832 (4 trials) | ⊕⊕⊕⊕ high3,6,7,12 |
| Severe adverse effects13 | ‐ | ‐ | ‐ | ‐ (0 trials) |
‐ |
| *The basis for the assumed risk (eg the median control group risk across trials) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio. | |||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | |||||
1 Downgraded by 1 for risk of bias: Only one of these trials adequately described allocation concealment to be considered at low risk of selection bias. 2 Downgraded by 2 for imprecision: These trials were not adequately powered to detect a difference in mortality. Only 15 deaths occurred in these two trials. To confidently detect a 50% reduction in maternal mortality in a setting of 350 deaths/100,000 would require a sample size of over 100,000. 3 No serious risk of bias: Exclusion of the trials at high risk of bias did not change the statistical significance or clinical importance of the result. 4 No serious inconsistency: This finding was consistent across all trials and statistical heterogeneity was low. 5 No serious indirectness: These trials were conducted in Kenya and Mozambique between 1996 and 2005, all three trials administered IPT with SP. The definition of severe anaemia was variable; Hb < 8 g/dL, Hb < 7g/dL, or PCV < 21%. 6 No serious imprecision: This result is statistically significant and the meta‐analysis is adequately powered to detect this effect. 7 No serious inconsistency: Although statistical heterogeneity was high, all trials favoured IPT with SP but there was variability in the size of the effect. 8 No serious indirectness: These trials were conducted Kenya between 1996 and 1999. The definition of anaemia was variable; Hb < 11 g/dL, Hb < 10 g/dL. 9 Downgraded by 1 for risk of bias: This trial is at unclear risk of selection bias. 10 Downgraded by 1 for indirectness: This trial from Mozambique 2002, measured fever history only as proxy for malaria illness. 11 Downgraded by 1 for serious imprecision: The 95% CI is wide and includes clinically important benefits and no effect. 12 No serious indirectness: These trials were conducted in the Kenya and Mozambique between 1996 and 2005. 13Reporting of adverse events was generally poor. No severe adverse events were reported.