Summary of findings 6. Summary of findings table 6.
| Malaria chemoprevention for pregnant women (all parities) living in endemic areas: infant outcomes | |||||
| Patient or population: Pregnant women (all parities) Settings: Malaria‐endemic areas Intervention: Malaria chemoprevention (any regimen) 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 | Chemoprevention | ||||
| Spontaneous abortion | 12 per 1000 | 11 per 1000 (7 to 16) | RR 0.89 (0.58 to 1.36) | 5767 (3 trials) | ⊕⊕⊝⊝ low1,2,3,4 |
| Stillbirth | 22 per 1000 | 22 per 1000 (17 to 30) | RR 1.02 (0.76 to 1.36) | 7130 (5 trials) | ⊕⊕⊕⊝ moderate1,2,5 |
| Perinatal mortality | 33 per 1000 | 41 per 1000 (31 to 54) | RR 1.24 (0.94 to 1.63) | 5216 (4 trials) | ⊕⊕⊕⊝ moderate1,2,5 |
| Neonatal mortality | 62 per 1000 | 56 per 1000 (44 to 72) | RR 0.91 (0.71 to 1.16) | 6313 (5 trials) | ⊕⊕⊕⊝ moderate1,2,5 |
| Preterm birth | 85 per 1000 | 81 per 1000 (55 to 117) | RR 0.95 (0.65 to 1.38) | 1174 (2 trials) | ⊕⊕⊝⊝ low2,5,6,10 |
| Low birthweight | 119 per 1000 | 126 per 1000 (106 to 151) | RR 1.06 (0.89 to 1.27) | 3644 (4 trials) | ⊕⊕⊝⊝ low1,2,5,10 |
| Mean birthweight | The mean birthweight in the control groups ranged from 2797 g to 3161 g |
The mean birthweight in the intervention groups was 0.54 g lower (24.6 g lower to 23.6 g higher) | ‐ | 6007 (5 trials) | ⊕⊕⊕⊝ moderate1,7,8,10 |
| Placental parasitaemia | 181 per 1000 | 80 per 1000 (27 to 233) | RR 0.44 (0.15 to 1.29) | 3200 (4 trials) | ⊕⊕⊝⊝ low1,9,10 |
| *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 No serious risk of bias: The two most recent trials adequately described allocation concealment to be considered at low risk of selection bias. 2 No serious inconsistency: The finding of no difference is consistent across trials and statistical heterogeneity is low 3 No serious indirectness: These trials were conducted in the Burkina Faso, Mozambique and Uganda between 1988 and 2008. One gave chemoprevention as weekly chloroquine and two trials gave IPT with SP. 4 Downgraded by 2 for very serious imprecision: The 95% CI is wide and sample remains underpowered to detect or rule out an effect. 5 Downgraded by 1 for serious imprecision: The 95% CI is wide and sample remains underpowered to detect or rule out an effect. 6 No serious risk of bias: The most recent trial adequately described allocation concealment to be considered at low risk of selection bias. 7 No serious inconsistency: Although substantial statistical heterogeneity is present (I2 = 72%), this relates to the oldest trial which found a benefit with chemoprevention. The subsequent four trials have consistently found no clinically important difference. 8 No serious imprecision: The 95% CI probably excludes clinically important benefits. 9 Downgraded by 1 for serious inconsistency: The two old trials from 1957 and 1988 suggest clinically important benefits with chemoprophylaxis ‐ however, the two recent trials providing two doses of SP find no evidence of an effect. 10 Downgraded by 1 for serious indirectness: The finding of no effect in the recent trials may be due to the declining efficacy of two doses of SP which is no longer recommended.