Table 1

Study intervention on pregnant women, following the SPIRIT guideline recommendations

Time pointStudy period
EnrolmentRandomisationPostrandomisation
Screening0ANC1 (0−13 weeks+6 days)ANC2 (14–27 weeks+6 days)ANC3 (28–35 weeks+6 days)ANC4
(36–38 weeks)
Delivery28-day newborn assessment
Enrolment
 Informed consentX
 Eligibility screeningX
 RandomisationX
Arms
 Standard of care (S)Embedded Image
 Intervention (I)Embedded Image
Assessments
 Obstetric ultrasoundS, I
 Haemoglobin testS, IS, IS, IS, IS, I
 Malaria test with microscopyI, S*I, S*I, S*I, S*I, S*
 Malaria test with RDTIIIII
 Malaria test with LAMPIIIII
 Sample storageS, IS, IS, IS, IS, I
 Newborn assessmentS, IS, I
 Newborn weightS, IS, I
 Placenta weightS, I
 Placenta blood smearS, I
  • *Only women symptomatic in the standard of care arm.

  • ANC, antenatal care; LAMP, loop-mediated isothermal amplification; RDT, rapid diagnostic test; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.