Effectiveness of intermittent screening and treatment for the control of malaria in pregnancy: a cluster randomised trial in India

Abstract

BackgroundThe 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.MethodsA 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.ResultsBetween 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.ConclusionISTp 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.

Evaluation of Implementation of Intermittent Screening and Treatment for Control of Malaria in Pregnancy in Jharkhand, India

“…Health workers expressed support for ISTp in this study primarily because they believed that not all pregnant women with malaria were symptomatic, which in this context meant febrile. These beliefs are supported by the findings of the randomized trial on ISTp versus PCD, 12 and similar findings have recently been reported in Indonesia. 9 Passive case detection as a strategy requires that malaria is symptomatic and, therefore, is not effective in contexts such as Eastern India, where a large number of cases of malaria are, in fact, asymptomatic.…”

“…19 The proportion of women who reported that they were malaria positive or treated for malaria was the same in the pre-and post-implementation surveys. This is not unexpected as the prevalence of malaria was found to be very low in this setting (< 5.0% based on testing 3,300 women in a neighboring district 12 ), and less than half of women were tested, and this indicator was based on reports of women.…”

“…This study was conducted alongside a cluster-randomized controlled trial undertaken to assess the effectiveness of ISTp compared with PCD on placental malaria. 12 The aim of the study was to evaluate implementation of screening for malaria using RDTs at ANC within the routine health system in Jharkhand, India. The evaluation aimed to answer two main questions: first, what changes in ANC clinic attendance, screening, and/or testing for malaria occurred after implementation of ISTp; and second, what were the perspectives of health workers and pregnant women on screening for malaria at each visit to an ANC clinic.…”

Placental Malaria

“…The results have been unfavorable. On study in a low transmission setting found no additional benefit in placental malaria to ISTp in comparison with treating symptomatic patients [72]. Another study in an endemic region demonstrated that ISTp with DP when compared with IPTp with SP had higher levels of placental malaria and adverse obstetrical outcomes [67].…”

“…ISTp, the intermittent screening for malaria during antenatal visits using a rapid diagnostic test and treating test-positive women with an effective antimalarial drug [72], has been studied as a potential alternative to IPTp both in areas of SP and areas of low transmission where IPTp is not a recommendation. The results have been unfavorable.…”