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Effectiveness of intermittent screening and treatment for the control of malaria in pregnancy: a cluster randomised trial in India
  1. Irene Kuepfer1,
  2. Neelima Mishra2,
  3. Jane Bruce1,
  4. Vinit Mishra2,
  5. Anupkumar R Anvikar2,
  6. Sanghamitra Satpathi3,
  7. Prativa Behera3,
  8. Atis Muehlenbachs4,
  9. Jayne Webster1,
  10. Feiko terKuile5,
  11. Brian Greenwood1,
  12. Neena Valecha2,
  13. Daniel Chandramohan1
  1. 1Department of Disease Control, London School of Hygiene & Tropical Medicine Faculty of Infectious and Tropical Diseases, London, UK
  2. 2National Institute of Malaria Research, New Delhi, India
  3. 3Department of Pathology, Ispat General Hospital, Rourkela, India
  4. 4Office of Infectious Diseases, National Foundation for the Centers for Disease Control and Prevention Inc, Atlanta, Georgia, USA
  5. 5Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK
  1. Correspondence to Dr Irene Kuepfer; irene.kuepfer{at}lshtm.ac.uk

Abstract

Background The control of malaria in pregnancy (MiP) in India relies on testing women who present with symptoms or signs suggestive of malaria. We hypothesised that intermittent screening and treatment for malaria at each antenatal care visit (ISTp) would improve on this approach and reduce the adverse effects of MiP.

Methods A cluster randomised controlled trial comparing ISTp versus passive case detection (PCD) was conducted in Jharkhand state. Pregnant women of all parities with a gestational age of 18–28 weeks were enrolled. Women in the ISTp group were screened with a rapid diagnostic test (RDT) for malaria at each antenatal clinic visit and those in the PCD group were screened only if they had symptoms or signs suggestive of malaria. All RDT positive women were treated with artesunate/sulfadoxine–pyrimethamine. The primary endpoint was placental malaria, determined by placental histology, and the key secondary endpoints were birth weight, gestational age, vital status of the newborn baby and maternal anaemia.

Results Between April 2012 and September 2015, 6868 women were enrolled; 3300 in 46 ISTp clusters and 3568 in 41 PCD clusters. In the ISTp arm, 4.9% of women were tested malaria positive and 0.6% in the PCD arm. There was no difference in the prevalence of placental malaria in the ISTp (87/1454, 6.0%) and PCD (65/1560, 4.2%) groups (6.0% vs 4.2%; OR 1.34, 95% CI 0.78 to 2.29, p=0.29) or in any of the secondary endpoints.

Conclusion ISTp detected more infections than PCD, but monthly ISTp with the current generation of RDT is unlikely to reduce placental malaria or impact on pregnancy outcomes. ISTp trials with more sensitive point-of-care diagnostic tests are needed.

  • malaria
  • pregnancy
  • prevention and control
  • intermittent screening and treatment
  • India

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Footnotes

  • Handling editor Soumitra Sudip Bhuyan

  • Contributors DC, JW, FtK and BG conceived the idea of the study. DC, JW, NV, AKA and NM initiated the study design. ISK, DC and VM helped with the implementation. ARM, SS and PB were doing the histopathological evaluation of the placental biopsies. JB provided statistical expertise in clinical trial design and was conducting the primary statistical analysis. All the authors contributed to the refinement of the study protocol and approved the final manuscript.

  • Funding The study was funded by the Malaria in Pregnancy Consortium, which was funded through a grant from the Bill & Melinda Gates Foundation to the Liverpool School of Tropical Medicine.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval Ethics Committee London School of Hygiene & Tropical Medicine, 6017 Institutional Ethics Committee of the National Institute of Malaria Research, Delhi, India (approval was given without specific ID) and Government of India, Ministry of Tribal Affairs (approval was given without specific ID).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available on reasonable request.

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