Time point | Study period | |||||||
Enrolment | Randomisation | Postrandomisation | ||||||
Screening | 0 | ANC1 (0−13 weeks+6 days) | ANC2 (14–27 weeks+6 days) | ANC3 (28–35 weeks+6 days) | ANC4 (36–38 weeks) | Delivery | 28-day newborn assessment | |
Enrolment | ||||||||
Informed consent | X | |||||||
Eligibility screening | X | |||||||
Randomisation | X | |||||||
Arms | ||||||||
Standard of care (S) | ||||||||
Intervention (I) | ||||||||
Assessments | ||||||||
Obstetric ultrasound | S, I | |||||||
Haemoglobin test | S, I | S, I | S, I | S, I | S, I | |||
Malaria test with microscopy | I, S* | I, S* | I, S* | I, S* | I, S* | |||
Malaria test with RDT | I | I | I | I | I | |||
Malaria test with LAMP | I | I | I | I | I | |||
Sample storage | S, I | S, I | S, I | S, I | S, I | |||
Newborn assessment | S, I | S, I | ||||||
Newborn weight | S, I | S, I | ||||||
Placenta weight | S, I | |||||||
Placenta blood smear | S, 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.