Last Updated: 20/06/2024

IPTp Study: Highly-sensitive RDT diagnostic efficacy in placental blood

Objectives

The primary objective is to determine if IPTp-DP is more effective than and as safe as IPTp-SP in preventing maternal malaria at the time of delivery and to determine its effect on foetal morbidity.

The primary outcome is to determine the presence or absence of malaria infection at delivery, any species, detected at the time of delivery in either:

  • Placental blood by microscopy, PCR or RDT/ Highly-sensitive RDT
  • Placental tissue by histology
  • Peripheral maternal blood by microscopy or RDT/ Highly-sensitive RDT
Principal Investigators / Focal Persons

Julie Gutman
Don P. Mathanga

Rationale and Abstract

  • Outcome measures: (Individual level) Test positivity in placental blood and peripheral maternal blood
  • Gold standard: PCR
  • Comparators: PCR, RDT, microscopy
  • Population selection criteria: HIV-negative pregnant women at 16-28 weeks of gestation residents of the study catchment area
  • Population sample size: n=602 (301 per study arm) women

Study Design

Population cross-sectional survey (testing a cohort of women followed since 1st ANC visit at the time of delivery)

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