Publications

Background: Pregnancy poses specific challenges in the diagnosis of Plasmodium falciparum infection due to parasite sequestration in the placenta. The diagnosis of Plasmodium falciparum infection in pregnant mothers therefore requires highly sensitive methods in order to detect the presence of parasites. These include those that detect the presence of antigens and those that detect and quantify the presence of the malaria parasites.Objective: The study assessed the performance of mRDT diagnostic test ((PfHRP2-RDT) in the detection of malaria infection in blood samples from nulliparous pregnant women within the first trimester of pregnancy in Western Kenya.Methods: This was a prospective study on blood specimens collected from pregnant women in a malaria-endemic region in Kenya. m-polymerase chain reaction (mPCR) and mRDT tests were performed. The diagnostic accuracy of m-RDT was compared with mPCR as the gold standard for the purpose of this study.Setting: Twelve primary health facilities in Busia, Bungoma and Kakamega Counties in KenyaResults: Out of 264 mPCR positive samples, 130 were mRDT positive (true positives) while 134 were mRDT negative (false negative). And out of 441 mPCR negative samples, 41 were positive on mRDT (false positive). Thus, in comparison with mPCR, the sensitivity and specificity of mRDT to detect malaria infection in nulliparous pregnant mothers in first trimester was 49.2% and 88.9% respectivelyConclusions: The sensitivity of mRDT to detect Plasmodium falciparum infections in nulliparous pregnant mothers in the first trimester was not satisfactory compared to mPCR tests.

BACKGROUND: The use of azithromycin reduces maternal infection in women during unplanned cesarean delivery, but its effect on those with planned vaginal delivery is unknown. Data are needed on whether an intrapartum oral dose of azithromycin would reduce maternal and offspring sepsis or death. METHODS: In this multicountry, placebo-controlled, randomized trial, we assigned women who were in labor at 28 weeks' gestation or more and who were planning a vaginal delivery to receive a single 2-g oral dose of azithromycin or placebo. The two primary outcomes were a composite of maternal sepsis or death and a composite of stillbirth or neonatal death or sepsis. During an interim analysis, the data and safety monitoring committee recommended stopping the trial for maternal benefit. RESULTS: A total of 29,278 women underwent randomization. The incidence of maternal sepsis or death was lower in the azithromycin group than in the placebo group (1.6% vs. 2.4%), with a relative risk of 0.67 (95% confidence interval [CI], 0.56 to 0.79; P<0.001), but the incidence of stillbirth or neonatal death or sepsis was similar (10.5% vs. 10.3%), with a relative risk of 1.02 (95% CI, 0.95 to 1.09; P = 0.56). The difference in the maternal primary outcome appeared to be driven mainly by the incidence of sepsis (1.5% in the azithromycin group and 2.3% in the placebo group), with a relative risk of 0.65 (95% CI, 0.55 to 0.77); the incidence of death from any cause was 0.1% in the two groups (relative risk, 1.23; 95% CI, 0.51 to 2.97). Neonatal sepsis occurred in 9.8% and 9.6% of the infants, respectively (relative risk, 1.03; 95% CI, 0.96 to 1.10). The incidence of stillbirth was 0.4% in the two groups (relative risk, 1.06; 95% CI, 0.74 to 1.53); neonatal death within 4 weeks after birth occurred in 1.5% in both groups (relative risk, 1.03; 95% CI, 0.86 to 1.24). Azithromycin was not associated with a higher incidence in adverse events. CONCLUSIONS: Among women planning a vaginal delivery, a single oral dose of azithromycin resulted in a significantly lower risk of maternal sepsis or death than placebo but had little effect on newborn sepsis or death. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; A-PLUS ClinicalTrials.gov number, NCT03871491.).