Effective and safe treatment for malaria in pregnancy in India: a randomised controlled trial.
Dr Neena Valecha (NIMR, India) and Prof Daniel Chandramohan (LSHTM, UK)Co-Principal investigators:
Dr Anupkumar Anvikar, Prof A P Dash (NIMR, India) and Prof Feiko ter Kuile (LSTM, UK)Project Partners:
Dr V Udhayakumar (CDC, USA), Prof Francois Nosten (Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Thailand)
The primary objective of this trial was to assess the efficacy of artesunate-mefloquine compared to artesunate-sulphadoxine-pyrimethamine for treatment of falciparum malaria in pregnancy in India, with a secondary objective to assess the safety and tolerability.Study design
This randomised open-label active-controlled clinical trial enrolled 248 pregnant women in second and third trimesters of pregnancy with P. falciparum infections. The trial was undertaken in three sites in Jharkhand and Odisha States, India.Results and Conclusion
The cure rates of artesunate-sulphadoxine-pyrimethamine and artesunate-mefloquine by day 63 were 95.2% and 95.1% respectively. There was no significant difference in the safety and tolerability of these two ACTs for the treatment of uncomplicated P.falciparum malaria in pregnant women in the second and third trimester. Given that not all cases of malaria are symptomatic, active screening of pregnant women during routine antenatal clinic appointments is recommended and treatment of positive cases with first line treatment.Impact of the research
The evidence generated from the trial and sub-studies will provide the basis for policy review for the control of malaria in pregnancy in India