The Performance of a Rapid Diagnostic Test in Detecting Malaria Infection in Pregnant Women and the Impact of Missed Infections

Williams, John E.; Cairns, Matthew; Njie, Fanta; Quaye, Stephen Laryea; Awine, Timothy; Oduro, Abraham; Tagbor, Harry; Bojang, Kalifa; Magnussen, Pascal; Kuile, Feiko O. ter; Woukeu, Arouna; Milligan, Paul; Chandramohan, Daniel; Greenwood, Brian

doi:10.1093/cid/civ1198

Cited by 33 publications

(38 citation statements)

References 26 publications

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“…The sensitivity of RDTs in pregnancy is lower than in non-pregnant populations 16 17. In our study, the observed sensitivity of RDTs to detect histology-confirmed placental malaria was 11.5%, similar to the sensitivity of 10% reported from Indonesia18 but lower to the sensitivity reported from Africa (73%, 95% CI 64 to 81) 19…”

Section: Discussionsupporting

confidence: 74%

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

et al. 2019

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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.

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Section: Discussionsupporting

confidence: 74%

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

et al. 2019

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“…ISTp-DP may also have been ineffective owing to a failure to detect low-level parasitemias, although the biological impact of such infections during pregnancy is unclear [ 35 ]. RDTs detected about 45% of the PCR-positive infections in paucigravidae and about 30% in multigravidae, thereby allowing the majority of infections to persist in the placenta.…”

Section: Discussionmentioning

confidence: 99%

Scheduled Intermittent Screening with Rapid Diagnostic Tests and Treatment with Dihydroartemisinin-Piperaquine versus Intermittent Preventive Therapy with Sulfadoxine-Pyrimethamine for Malaria in Pregnancy in Malawi: An Open-Label Randomized Controlled Trial

et al. 2016

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BackgroundIn Africa, most plasmodium infections during pregnancy remain asymptomatic, yet are associated with maternal anemia and low birthweight. WHO recommends intermittent preventive therapy in pregnancy with sulfadoxine-pyrimethamine (IPTp-SP). However, sulfadoxine-pyrimethamine (SP) efficacy is threatened by high-level parasite resistance. We conducted a trial to evaluate the efficacy and safety of scheduled intermittent screening with malaria rapid diagnostic tests (RDTs) and treatment of RDT-positive women with dihydroartemisinin-piperaquine (DP) as an alternative strategy to IPTp-SP.Methods and FindingsThis was an open-label, two-arm individually randomized superiority trial among HIV-seronegative women at three sites in Malawi with high SP resistance. The intervention consisted of three or four scheduled visits in the second and third trimester, 4 to 6 wk apart. Women in the IPTp-SP arm received SP at each visit. Women in the intermittent screening and treatment in pregnancy with DP (ISTp-DP) arm were screened for malaria at every visit and treated with DP if RDT-positive. The primary outcomes were adverse live birth outcome (composite of small for gestational age, low birthweight [<2,500 g], or preterm birth [<37 wk]) in paucigravidae (first or second pregnancy) and maternal or placental plasmodium infection at delivery in multigravidae (third pregnancy or higher). Analysis was by intention to treat.Between 21 July 2011 and 18 March 2013, 1,873 women were recruited (1,155 paucigravidae and 718 multigravidae). The prevalence of adverse live birth outcome was similar in the ISTp-DP (29.9%) and IPTp-SP (28.8%) arms (risk difference = 1.08% [95% CI −3.25% to 5.41%]; all women: relative risk [RR] = 1.04 [95% CI 0.90–1.20], p = 0.625; paucigravidae: RR = 1.10 [95% CI 0.92–1.31], p = 0.282; multigravidae: RR = 0.92 [95% CI 0.71–1.20], p = 0.543). The prevalence of malaria at delivery was higher in the ISTp-DP arm (48.7% versus 40.8%; risk difference = 7.85%, [95% CI 3.07%–12.63%]; all women: RR = 1.19 [95% CI 1.07–1.33], p = 0.007; paucigravidae: RR = 1.16 [95% CI 1.04–1.31], p = 0.011; multigravidae: RR = 1.29 [95% CI 1.02–1.63], p = 0.037). Fetal loss was more common with ISTp-DP (2.6% versus 1.3%; RR = 2.06 [95% CI 1.01–4.21], p = 0.046) and highest among non-DP-recipients (3.1%) in the ISTp-DP arm. Limitations included the open-label design.ConclusionsScheduled screening for malaria parasites with the current generation of RDTs three to four times during pregnancy as part of focused antenatal care was not superior to IPTp-SP in this area with high malaria transmission and high SP resistance and was associated with higher fetal loss and more malaria at delivery.Trial RegistrationPan African Clinical Trials Registry PACTR201103000280319; ISRCTN Registry ISRCTN69800930

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“…This is important given the results of the current trial which found that RDTs only detected around 45% of PCR-positive infections in paucigravidae and 30% in multigravidae; as women were treated according to RDT result, this may explain the higher prevalence of malaria infections at delivery in the ISTp-DP arm [22]. However, it is important to note that the biological impact of such low-level parasitaemia during pregnancy is unclear [37, 38] and the incidence of clinical malaria was not significantly different between the trial arms [22]. Compliance with RDT result was not an issue in the trial setting but it is unclear whether or not non-compliance would be observed in a screening strategy involving asymptomatic pregnant women under routine conditions.…”

Section: Discussionmentioning

confidence: 99%

Provider and user acceptability of intermittent screening and treatment for the control of malaria in pregnancy in Malawi

Almond

Madanitsa

Mwapasa

et al. 2016

Malar J

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BackgroundMalaria in pregnancy is a major cause of adverse maternal and fetal outcomes. Intermittent preventive treatment with sulfadoxine–pyrimethamine (IPTp-SP) is one of the control strategies promoted by WHO. In response to mounting resistance to SP, intermittent screening and treatment (ISTp) has been proposed as an alternative. The objective of this study was to explore the acceptability of ISTp for health workers and pregnant women.MethodsSemi-structured interviews of ten health workers and five focus group discussions of 38 women enrolled in an ongoing trial comparing IPTp-SP and ISTp with dihydroartemisinin–piperaquine (DP) were conducted at two antenatal clinics in rural Malawi. All transcripts were coded and themes were identified using a content analysis approach.ResultsAmongst health workers, there were contrasting opinions on the preference of blood sampling methods, and the influence of method on reliability of diagnosis. The perceived greater effectiveness of DP compared to SP was appreciated, however concerns of user compliance with the full dose of DP in non-trial settings were raised. Despite the discomfort of repeated finger pricks, pregnant women were generally accepting of ISTp, particularly the chance for regular blood tests to check for infections and the perceived greater effectiveness with fewer side effects of DP compared to SP.ConclusionIn the trial context, pregnant women tended to prefer ISTp-DP over IPTp-SP. Health workers were also accepting of ISTp-DP as an alternative to IPTp-SP in light of increasing SP resistance. However, reliability of stock, adherence to malaria test results and user adherence to the full course of DP may present barriers to successful routine implementation. Effective communication with health workers and between health workers, pregnant women and their communities will be essential for the acceptability of focused antenatal care, including the best malaria control measures available.

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The Performance of a Rapid Diagnostic Test in Detecting Malaria Infection in Pregnant Women and the Impact of Missed Infections

Abstract: The sensitivity of a rapid diagnostic test (RDT) for malaria was compared with that of a polymerase chain reaction assay in pregnant West African women. The sensitivity of the RDT was high at enrollment but lower at delivery.

Cited by 33 publications

References 26 publications

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

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

Scheduled Intermittent Screening with Rapid Diagnostic Tests and Treatment with Dihydroartemisinin-Piperaquine versus Intermittent Preventive Therapy with Sulfadoxine-Pyrimethamine for Malaria in Pregnancy in Malawi: An Open-Label Randomized Controlled Trial

Provider and user acceptability of intermittent screening and treatment for the control of malaria in pregnancy in Malawi

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