Intermittent Preventive Treatment With Azithromycin-containing Regimens for the Prevention of Malarial Infections and Anaemia and the Control of Sexually Transmitted Infections in Pregnant Women in Papua New Guinea

简要总结

主要结局

次要结局

• Prevalence of P falciparum at delivery in peripheral, placental and cord blood films and on placental histology(at delivery)
• Mean maternal hemoglobin concentration at delivery, and proportion of women anaemic (Hb < 11 g/dl).(At delivery)
• Prevalence (at enrolment, second treatment, and delivery) and consequences (maternal haemoglobin, birth weight and placental pathology) of P. vivax infection in pregnancy(up to 26 weeks)
• Incidence of symptomatic malaria during pregnancy(Up to 26 weeks)
• Proportion of women carrying azithromycin-sensitive sexually transmitted infections at second treatment visit (28-34 weeks).(28-34 week gestation study visit)
• Incidence of Adverse Events, including severe adverse events (SAEs), and AEs possibly or probably associated with study medications(14-26 weeks)
• Prevalence of drug resistance markers in parasites infecting women in late pregnancy, particularly in the P falciparum and P vivax dihydrofolate reductase and dihydropteroate synthase enzymes, associated with SP resistance(at delivery)
• Prevalence and antibiotic sensitivity patterns of S. pneumoniae in nasopharyngeal swabs collected at delivery(at delivery)
• Maternal, perinatal and infant mortality rates(Mothers; up to 32 weeks, from enrolment at 14-26 weeks gestation, until delivery. Pernatal: 16 weeks, from 28 weeks gestation to 4 weeks of age. Infant: from live birth to 1 year of age)
• Impact of IPTp on development of immunity to malaria in pregnancy(at delivery)
• Characteristics of parasites infecting pregnant women(Up to 26 weeks, from 14-26 weeks gestation until delivery)