McGready 2001.
Methods | RCT Trial duration: 17 months between April 1995 and September 1996. |
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Participants | Participants were women who were 3 to 7 months' pregnant. Participants were not screened at start for P. vivax. |
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Interventions | 20% DEET added to Thanaka (popular local cosmetic) compared to Thanaka alone. Co‐intervention: none Treatment arms: ‐ Thanaka containing 20% DEET arm ‒ 449; and ‐ Thanaka arm ‒ 448. |
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Outcomes | ‐ Participants with malaria parasitaemia confirmed through blood smears (P. falciparum andP. vivax); ‐ Adherence to regular usage of the intervention measured through self‐reporting; ‐ Anaemia; and ‐ Recorded adverse events. |
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Notes | The study was carried out in camps for displaced people of the Karen ethnic minority in endemic regions of Thailand. The project was funded by the Danish Bilharziasis Laboratory and was part of the Wellcome‒Mahidol University of Oxford Tropical Medicine Research Programme funded by the Wellcome Trust. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) Parasitaemia | Low risk | Double‐blinded RCT, both personnel and participants were blinded to the intervention. |
Blinding of participants and personnel (performance bias) Anaemia | Low risk | Double‐blinded RCT, both personnel and participants were blinded to the intervention. |
Blinding of participants and personnel (performance bias) Compliance | Low risk | Double‐blinded RCT, both personnel and participants were blinded to the intervention. |
Blinding of participants and personnel (performance bias) Adverse events | Low risk | Double‐blinded RCT, both personnel and participants were blinded to the intervention. |
Blinding of outcome assessment (detection bias) Parasitaemia | Low risk | Double‐blinded RCT, both personnel and participants were blinded to the intervention. |
Blinding of outcome assessment (detection bias) Compliance | Low risk | Double blinded RCT, both personnel and participants were blinded to the intervention. |
Blinding of outcome assessment (detection bias) Adverse events | Low risk | Double‐blinded RCT, both personnel and participants were blinded to the intervention. |
Blinding of outcome assessment (detection bias) Anaemia | Low risk | This is an objective outcome. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition between arms was similar, data was not reported in the published but retrieved through communication with the author. |
Selective reporting (reporting bias) | Low risk | Reporting was not clear in the published article but data of events between treatment arms was sent to us after communicating with the author. |
Other bias | Low risk | Baseline imbalance "Between April 1995 and September 1996, 897 pregnant women were enrolled in the study, 449 into the DET and thanaka group and 448 into the thanaka alone group with no difference in baseline characteristics" |