Mefloquine for preventing malaria in pregnant women

Raquel González; Clara Pons‐Duran; Mireia Piqueras; John J Aponte; Feiko O ter Kuile; Clara Menéndez

doi:10.1002/14651858.CD011444.pub2

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Figure 1

Indicators and impact of malaria infection in mothers and infants.

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Figure 2

Conceptual framework of malaria chemoprevention. Reproduced under the terms of a Creative Commons Licence from Radeva‐Petrova 2014.

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Figure 3

Study flow diagram.

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Figure 4

‘Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

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Figure 5

‘Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Analysis 1.1

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 1 Clinical malaria episodes during pregnancy.

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Analysis 1.2

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 2 Maternal peripheral parasitaemia at delivery.

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Analysis 1.3

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 3 Placental malaria.

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Analysis 1.4

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 4 Mean haemoglobin at delivery.

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Analysis 1.5

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 5 Maternal anaemia at delivery.

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Analysis 1.6

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 6 Severe maternal anaemia at delivery.

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Analysis 1.7

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 7 Cord blood parasitaemia.

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Analysis 1.8

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 8 Cord blood anaemia.

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Analysis 1.9

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 9 Mean birth weight.

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Analysis 1.10

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 10 Low birth weight.

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Analysis 1.11

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 11 Low birth weight by gravidity.

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Analysis 1.12

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 12 Prematurity.

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Analysis 1.13

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 13 Malaria in first year of life.

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Analysis 1.14

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 14 Hospital admissions in first year of life.

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Analysis 1.15

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 15 SAEs during pregnancy.

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Analysis 1.16

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 16 Stillbirths and abortions.

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Analysis 1.17

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 17 Congenital malformations.

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Analysis 1.18

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 18 Maternal mortality.

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Analysis 1.19

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 19 Neonatal mortality.

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Analysis 1.20

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 20 Infant mortality.

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Analysis 1.21

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 21 AEs: vomiting.

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Analysis 1.22

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 22 AEs: fatigue/weakness.

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Analysis 1.23

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 23 AEs: dizziness.

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Analysis 1.24

Comparison 1 Mefloquine versus sulfadoxine‐pyrimethamine, Outcome 24 AEs: headache.

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Analysis 2.1

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 1 Clinical malaria episodes during pregnancy.

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Analysis 2.2

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 2 Maternal peripheral parasitaemia at delivery (PCR).

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Analysis 2.3

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 3 Placental malaria (blood smear).

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Analysis 2.4

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 4 Placental malaria (PCR).

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Analysis 2.5

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 5 Mean haemoglobin at delivery.

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Analysis 2.6

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 6 Maternal anaemia at delivery (< 9.5 g/dL).

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Analysis 2.7

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 7 Maternal severe anaemia at delivery.

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Analysis 2.8

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 8 Cord blood parasitaemia.

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Analysis 2.9

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 9 Mean birth weight.

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Analysis 2.10

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 10 Low birth weight.

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Analysis 2.11

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 11 Prematurity.

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Analysis 2.12

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 12 SAEs during pregnancy.

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Analysis 2.13

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 13 Spontaneous abortions and stillbirths.

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Analysis 2.14

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 14 Congenital malformations.

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Analysis 2.15

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 15 Maternal mortality.

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Analysis 2.16

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 16 Neonatal mortality.

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Analysis 2.17

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 17 Mother‐to‐child transmission HIV.

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Analysis 2.18

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 18 AEs: vomiting.

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Analysis 2.19

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 19 AEs: fatigue/weakness.

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Analysis 2.20

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 20 AEs: dizziness.

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Analysis 2.21

Comparison 2 Mefloquine plus cotrimoxazole versus cotrimoxazole, Outcome 21 AEs: headache.

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Analysis 3.1

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 1 Maternal peripheral parasitaemia at delivery (PCR).

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Analysis 3.2

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 2 Placental malaria (PCR).

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Analysis 3.3

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 3 Placental malaria (blood smear).

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Analysis 3.4

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 4 Mean haemoglobin at delivery.

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Analysis 3.5

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 5 Maternal anaemia at delivery (< 9.5 g/dL).

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Analysis 3.6

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 6 Mean birth weight.

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Analysis 3.7

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 7 Low birth weight.

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Analysis 3.8

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 8 Prematurity.

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Analysis 3.9

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 9 SAEs during pregnancy.

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Analysis 3.10

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 10 Stillbirths.

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Analysis 3.11

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 11 Spontaneous abortions.

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Analysis 3.12

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 12 Congenital malformations.

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Analysis 3.13

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 13 Maternal mortality.

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Analysis 3.14

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 14 Neonatal mortality.

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Analysis 3.15

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 15 Infant deaths after 7 days.

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Analysis 3.16

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 16 AEs: vomiting.

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Analysis 3.17

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 17 AEs: fatigue/weakness.

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Analysis 3.18

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 18 AEs: dizziness.

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Analysis 3.19

Comparison 3 Mefloquine versus cotrimoxazole, Outcome 19 AEs: headache.

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Analysis 4.1

Comparison 4 Mefloquine versus placebo, Outcome 1 Maternal peripheral parasitaemia during pregnancy.

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Analysis 4.2

Comparison 4 Mefloquine versus placebo, Outcome 2 Placental malaria.

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Analysis 4.3

Comparison 4 Mefloquine versus placebo, Outcome 3 Mean birth weight.

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Analysis 4.4

Comparison 4 Mefloquine versus placebo, Outcome 4 Low birth weight.

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Analysis 4.5

Comparison 4 Mefloquine versus placebo, Outcome 5 Prematurity.

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Analysis 4.6

Comparison 4 Mefloquine versus placebo, Outcome 6 Stillbirths.

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Analysis 4.7

Comparison 4 Mefloquine versus placebo, Outcome 7 Spontaneous abortions.

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Analysis 4.8

Comparison 4 Mefloquine versus placebo, Outcome 8 Congenital malformations.

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Analysis 4.9

Comparison 4 Mefloquine versus placebo, Outcome 9 Maternal mortality.

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Analysis 4.10

Comparison 4 Mefloquine versus placebo, Outcome 10 Infant mortality.

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Summary of findings for the main comparison. Mefloquine compared with sulfadoxine‐pyrimethamine for preventing malaria in pregnant women

Mefloquine compared with sulfadoxine‐pyrimethamine for preventing malaria in pregnant women
Patient or population: HIV‐uninfected pregnant women Setting: Benin, Gabon, Mozambique, and Tanzania Intervention: mefloquine Comparison: sulfadoxine‐pyrimethamine
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	Number of participants (trials)	Certainty of the evidence (GRADE)	Comments (compared with sulfadoxine‐pyrimethamine)
Outcomes	Risk with sulfadoxine‐pyrimethamine	Risk with mefloquine	Relative effect (95% CI)	Number of participants (trials)	Certainty of the evidence (GRADE)	Comments (compared with sulfadoxine‐pyrimethamine)
Clinical malaria episodes during pregnancy	‐	‐	IRR 0.83 (0.65 to 1.05)	‐ (2 RCTs)	⊕⊕⊕⊝ HIGH^a	Mefloquine results in little or no difference in the incidence of clinical malaria episodes during pregnancy
Maternal peripheral parasitaemia at delivery	43 per 1000	28 per 1000 (20 to 37)	RR 0.65 (0.48 to 0.86)	5455 (2 RCTs)	⊕⊕⊕⊝ HIGH^a	Mefloquine results in lower maternal peripheral parasitaemia at delivery
Placental malaria	52 per 1000	54 per 1000 (30 to 97)	RR 1.04 (0.58 to 1.86)	4668 (2 RCTs)	⊕⊕⊝⊝ LOW^a,b,c Due to imprecision and heterogeneity	Mefloquine may result in little or no difference in placental parasitaemia
Maternal anaemia at delivery	219 per 1000	184 per 1000 (166 to 206)	RR 0.84 (0.76 to 0.94)	5469 (2 RCTs)	⊕⊕⊕⊝ MODERATE^a,d Due to imprecision	Mefloquine probably results in fewer women anaemic at delivery
Low birth weight	117 per 1000	111 per 1000 (91 to 137)	RR 0.95 (0.78 to 1.17)	5641 (2 RCTs)	⊕⊕⊕⊝ HIGH^a	Mefloquine results in little or no difference in low birth weight
Stillbirths and abortions	31 per 1000	37 per 1000 (28 to 49)	RR 1.20 (0.91 to 1.58)	6219 (2 RCTs)	⊕⊕⊕⊝ HIGH^a	Mefloquine results in little or no difference in stillbirths or abortions
AEs: vomiting	82 per 1000	390 per 1000 (338 to 449)	RR 4.76 (4.13 to 5.49)	6272 (2 RCTs)	⊕⊕⊕⊕ HIGH^a	Mefloquine results in a four‐fold increase in vomiting
AEs: dizziness	94 per 1000	396 per 1000 (316 to 496)	RR 4.21 (3.36 to 5.27)	6272 (2 RCTs)	⊕⊕⊕⊝ HIGH^a,b	Mefloquine results in a four‐fold increase in dizziness
*The risk in the intervention group (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). Abbreviations: CI: confidence interval; IRR: incidence rate ratio; RCT: randomized controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.
^aAlthough one trial has serious risk of bias, the other is of high certainty and exclusion of the smaller trial has little effect on the estimate of effect. ^bDowngraded by 1 for imprecision: Confidence intervals range from considerable benefit to considerable harm. ^cDowngraded by 1 for heterogeneity: Substantive qualitative heterogeneity is evident in the meta‐analysis. ^dConfidence intervals include little or no important difference to a 24% reduction in anaemic women. The estimate of 16% is judged to be clinically important.

Summary of findings for the main comparison. Mefloquine compared with sulfadoxine‐pyrimethamine for preventing malaria in pregnant women

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Summary of findings 2. Mefloquine plus cotrimoxazole compared with cotrimoxazole for preventing malaria in pregnant women

Mefloquine plus cotrimoxazole compared with cotrimoxazole for preventing malaria in pregnant women
Patient or population: HIV‐infected pregnant women Setting: Benin, Kenya, Mozambique, and Tanzania Intervention: mefloquine plus cotrimoxazole Comparison: cotrimoxazole
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	Number of participants (trials)	Certainty of the evidence (GRADE)	Comments (compared with cotrimoxazole)
Outcomes	Risk with cotrimoxazole	Risk with mefloquine plus cotrimoxazole	Relative effect (95% CI)	Number of participants (trials)	Certainty of the evidence (GRADE)	Comments (compared with cotrimoxazole)
Clinical malaria episodes during pregnancy	‐	‐	IRR 0.76 (0.33 to 1.76)	‐ (1 RCT)	⊕⊕⊕⊕ HIGH	Mefloquine results in little or no difference in the incidence of clinical malaria episodes during pregnancy
Maternal peripheral parasitaemia at delivery (PCR)	66 per 1000	34 per 1000 (20 to 62)	RR 0.52 (0.30 to 0.93)	989 (2 RCTs)	⊕⊕⊕⊝ MODERATE^a	Mefloquine probably results in lower maternal peripheral parasitaemia at delivery
Placental malaria (PCR)	68 per 1000	19 per 1000 (10 to 39)	RR 0.28 (0.14 to 0.57)	977 (2 RCTs)	⊕⊕⊕⊕ HIGH^a	Mefloquine plus cotrimoxazole results in fewer women with placental malaria at delivery
Maternal anaemia at delivery	178 per 1000	168 per 1000 (130 to 214)	RR 0.94 (0.73 to 1.20)	1197 (2 RCTs)	⊕⊕⊕⊝ MODERATE^a	Mefloquine plus cotrimoxazole probably results in little or no difference in maternal anaemia cases at delivery
Low birth weight	118 per 1000	141 per 1000 (105 to 188)	RR 1.20 (0.89 to 1.60)	1220 (2 RCTs)	⊕⊕⊕⊝ MODERATE^a	Mefloquine plus cotrimoxazole probably results in little or no difference in low birth weight
Spontaneous abortions and stillbirths	50 per 1000	56 per 1000 (21 to 149)	RR 1.12 (0.42 to 2.98)	1347 (2 RCTs)	⊕⊝⊝⊝ VERY LOW^a,b,c	Mefloquine plus cotrimoxazole may result in little or no difference in spontaneous abortions and stillbirths
AEs: vomiting	30 per 1000	239 per 1000 (144 to 396)	RR 7.95 (4.79 to 13.18)	1055 (1 RCT)^d	⊕⊕⊕⊕ HIGH	Mefloquine plus cotrimoxazole results in an eight‐fold increase in vomiting
AEs: dizziness	75 per 1000	296 per 1000 (214 to 411)	RR 3.94 (2.85 to 5.46)	1055 (1 RCT)^e	⊕⊕⊕⊕ HIGH	Mefloquine plus cotrimoxazole results in a four‐fold increase in dizziness
*The risk in the intervention group (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). Abbreviations: CI: confidence interval; IRR: incidence rate ratio; RCT: randomized controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.
^aAlthough one trial has serious risk of bias, the other is of high certainty and exclusion of the smaller trial has little effect on the estimate of effect. ^bDowngraded by 1 for inconsistency: Trials showed substantial heterogeneity. ^cDowngraded by 1 for imprecision: Confidence intervals range from considerable benefit to considerable harm. ^dA second RCT, Denoeud‐Ndam 2014a BEN, reported 50 events in the mefloquine+cotrimoxazole group and 0 in the control group (cotrimoxazole), with RR 101 (95% CI 6.29 to 1621.68). This trial was open and participants knew to which group they were allocated. Meta‐analysis causes a paradoxically very wide CI. Because of this distortion, we have used the results from Gonzalez 2014b KEN MOZ TAN in the grade table. ^eA second RCT, Denoeud‐Ndam 2014a BEN, reported 52 events in the mefloquine+cotrimoxazole group and 0 in the control group (cotrimoxazole), with RR 105 (95% CI 6.54 to 1685.03). This trial was open and participants knew to which group they were allocated. Meta‐analysis causes a paradoxically very wide CI with the lower 95% CI. Because of this distortion, we have used the results from Gonzalez 2014b KEN MOZ TAN in this ‘Summary of findings' table.

Summary of findings 2. Mefloquine plus cotrimoxazole compared with cotrimoxazole for preventing malaria in pregnant women

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Comparison 1. Mefloquine versus sulfadoxine‐pyrimethamine

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clinical malaria episodes during pregnancy Show forest plot	2		Rate Ratio (Fixed, 95% CI)	0.83 [0.65, 1.05]

2 Maternal peripheral parasitaemia at delivery Show forest plot	2	5455	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.48, 0.86]

3 Placental malaria Show forest plot	2	4668	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.58, 1.86]

4 Mean haemoglobin at delivery Show forest plot	2	5588	Mean Difference (IV, Fixed, 95% CI)	0.10 [0.01, 0.19]

5 Maternal anaemia at delivery Show forest plot	2	5469	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.76, 0.94]

6 Severe maternal anaemia at delivery Show forest plot	2	5469	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.58, 1.48]

7 Cord blood parasitaemia Show forest plot	2	5309	Risk Ratio (M‐H, Random, 95% CI)	0.44 [0.13, 1.46]

8 Cord blood anaemia Show forest plot	1	4006	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.87, 1.23]

9 Mean birth weight Show forest plot	2	5241	Mean Difference (IV, Fixed, 95% CI)	2.52 [‐25.66, 30.69]

10 Low birth weight Show forest plot	2	5641	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.78, 1.17]

11 Low birth weight by gravidity Show forest plot	2	5641	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.84, 1.13]

11.1 Primigravidae	2	1576	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.80, 1.30]
11.2 Multigravidae	2	4065	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.78, 1.14]
12 Prematurity Show forest plot	2	4640	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.76, 1.40]

13 Malaria in first year of life Show forest plot	1		Rate Ratio (Fixed, 95% CI)	0.97 [0.82, 1.15]

14 Hospital admissions in first year of life Show forest plot	1		Rate Ratio (Fixed, 95% CI)	0.93 [0.75, 1.17]

15 SAEs during pregnancy Show forest plot	1	4674	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.81, 1.20]

16 Stillbirths and abortions Show forest plot	2	6219	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [0.91, 1.58]

17 Congenital malformations Show forest plot	2	5931	Risk Ratio (M‐H, Random, 95% CI)	1.10 [0.51, 2.37]

18 Maternal mortality Show forest plot	2	6219	Risk Ratio (M‐H, Random, 95% CI)	2.41 [0.27, 21.23]

19 Neonatal mortality Show forest plot	2	6134	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.67, 1.43]

20 Infant mortality Show forest plot	1		Rate Ratio (Fixed, 95% CI)	1.00 [0.66, 1.52]

21 AEs: vomiting Show forest plot	2	6272	Risk Ratio (M‐H, Fixed, 95% CI)	4.76 [4.13, 5.49]

22 AEs: fatigue/weakness Show forest plot	2	6272	Risk Ratio (M‐H, Random, 95% CI)	4.62 [1.80, 11.85]

23 AEs: dizziness Show forest plot	2	6272	Risk Ratio (M‐H, Random, 95% CI)	4.21 [3.36, 5.27]

24 AEs: headache Show forest plot	2	6272	Risk Ratio (M‐H, Random, 95% CI)	0.70 [0.25, 1.94]

Comparison 1. Mefloquine versus sulfadoxine‐pyrimethamine

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Comparison 2. Mefloquine plus cotrimoxazole versus cotrimoxazole

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clinical malaria episodes during pregnancy Show forest plot	1		Rate Ratio (Fixed, 95% CI)	0.76 [0.33, 1.76]

2 Maternal peripheral parasitaemia at delivery (PCR) Show forest plot	2	989	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.30, 0.93]

3 Placental malaria (blood smear) Show forest plot	2	1144	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.29, 0.89]

4 Placental malaria (PCR) Show forest plot	2	977	Risk Ratio (M‐H, Fixed, 95% CI)	0.28 [0.14, 0.57]

5 Mean haemoglobin at delivery Show forest plot	2	1167	Mean Difference (IV, Random, 95% CI)	0.07 [‐0.32, 0.46]

6 Maternal anaemia at delivery (< 9.5 g/dL) Show forest plot	2	1197	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.73, 1.20]

7 Maternal severe anaemia at delivery Show forest plot	2	1167	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.41, 2.08]

8 Cord blood parasitaemia Show forest plot	2	1166	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.03, 3.13]

9 Mean birth weight Show forest plot	2	1220	Mean Difference (IV, Random, 95% CI)	‐25.75 [‐86.99, 35.49]

10 Low birth weight Show forest plot	2	1220	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [0.89, 1.60]

11 Prematurity Show forest plot	2	824	Risk Ratio (M‐H, Random, 95% CI)	1.07 [0.58, 1.96]

12 SAEs during pregnancy Show forest plot	2	1347	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.50, 0.95]

13 Spontaneous abortions and stillbirths Show forest plot	2	1347	Risk Ratio (M‐H, Random, 95% CI)	1.12 [0.42, 2.98]

14 Congenital malformations Show forest plot	2	1312	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.22, 1.67]

15 Maternal mortality Show forest plot	2	1347	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.13, 2.01]

16 Neonatal mortality Show forest plot	2	1239	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [0.65, 2.69]

17 Mother‐to‐child transmission HIV Show forest plot	2	1019	Risk Ratio (M‐H, Fixed, 95% CI)	1.92 [1.13, 3.25]

18 AEs: vomiting Show forest plot	2	1347	Risk Ratio (M‐H, Random, 95% CI)	20.88 [1.40, 311.66]

19 AEs: fatigue/weakness Show forest plot	2	1347	Risk Ratio (M‐H, Random, 95% CI)	2.95 [0.26, 32.93]

20 AEs: dizziness Show forest plot	2	1347	Risk Ratio (M‐H, Random, 95% CI)	16.34 [0.39, 684.99]

21 AEs: headache Show forest plot	2	1347	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.28, 2.10]

Comparison 2. Mefloquine plus cotrimoxazole versus cotrimoxazole

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Comparison 3. Mefloquine versus cotrimoxazole

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Maternal peripheral parasitaemia at delivery (PCR) Show forest plot	1	98	Risk Ratio (M‐H, Fixed, 95% CI)	0.21 [0.03, 1.72]

2 Placental malaria (PCR) Show forest plot	1	94	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.13, 4.15]

3 Placental malaria (blood smear) Show forest plot	1	108	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.01, 8.30]

4 Mean haemoglobin at delivery Show forest plot	1	100	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.67, 0.47]

5 Maternal anaemia at delivery (< 9.5 g/dL) Show forest plot	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.26, 3.16]

6 Mean birth weight Show forest plot	1	120	Mean Difference (IV, Fixed, 95% CI)	‐102.0 [‐255.52, 51.52]

7 Low birth weight Show forest plot	1	120	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [0.56, 4.13]

8 Prematurity Show forest plot	1	125	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.33, 3.56]

9 SAEs during pregnancy Show forest plot	1	140	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.28, 4.07]

10 Stillbirths Show forest plot	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	4.30 [0.49, 37.49]

11 Spontaneous abortions Show forest plot	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.07, 16.84]

12 Congenital malformations Show forest plot	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.16, 7.41]

13 Maternal mortality Show forest plot	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

14 Neonatal mortality Show forest plot	1	129	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.07, 16.39]

15 Infant deaths after 7 days Show forest plot	1	129	Risk Ratio (M‐H, Fixed, 95% CI)	2.10 [0.19, 22.54]

16 AEs: vomiting Show forest plot	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	13.43 [3.31, 54.54]

17 AEs: fatigue/weakness Show forest plot	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	6.99 [1.64, 29.81]

18 AEs: dizziness Show forest plot	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	52.60 [3.26, 848.24]

19 AEs: headache Show forest plot	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	0.21 [0.01, 4.39]

Comparison 3. Mefloquine versus cotrimoxazole

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Comparison 4. Mefloquine versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Maternal peripheral parasitaemia during pregnancy Show forest plot	1	339	Risk Ratio (M‐H, Fixed, 95% CI)	0.13 [0.05, 0.33]

2 Placental malaria Show forest plot	1	220	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.01, 2.68]

3 Mean birth weight Show forest plot	1	290	Mean Difference (IV, Fixed, 95% CI)	‐80.0 [‐184.65, 24.65]

4 Low birth weight Show forest plot	1	290	Risk Ratio (M‐H, Fixed, 95% CI)	1.39 [0.78, 2.48]

5 Prematurity Show forest plot	1	199	Risk Ratio (M‐H, Fixed, 95% CI)	0.48 [0.15, 1.53]

6 Stillbirths Show forest plot	1	311	Risk Ratio (M‐H, Fixed, 95% CI)	2.63 [0.86, 8.08]

7 Spontaneous abortions Show forest plot	1	311	Risk Ratio (M‐H, Fixed, 95% CI)	0.48 [0.04, 5.22]

8 Congenital malformations Show forest plot	1	311	Risk Ratio (M‐H, Fixed, 95% CI)	3.82 [0.43, 33.83]

9 Maternal mortality Show forest plot	1	339	Risk Ratio (M‐H, Fixed, 95% CI)	2.95 [0.12, 71.85]

10 Infant mortality Show forest plot	1	288	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.63, 1.74]

Comparison 4. Mefloquine versus placebo

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