Table 1.
Planned activities per visit for mothers
| Protocol activity | Visit 0 | Visit 1 | Visit 2 | Visit 3* | Visit 4 | Visit 5–6* | Visit 7 | Visit 8 |
| Day −7 to 0 | Day 0 | Day 28±2 days | 34 wks gestation±2 days | 36 wks. gestation±2 days | 38–40 wks gestation±2 days | Delivery+1 day | Day 28 postpartum±2 days | |
| Location of visit | Antenatal clinic | Research site† | Research site† | Home‡ | Research site† | Home‡ | Research site† | Research site† |
| Informed consent process for pre-screening | X | |||||||
| Pre-screening | X | |||||||
| Detailed informed consent process | X | X | ||||||
| Screening | X | |||||||
| Medical and obstetric history | X | |||||||
| Demographics | X | |||||||
| Maternal physical examination§ | X¶ | X** | X** | X§ | X** | |||
| Ultrasound scan (foetal biometry)§ | X | X | X | |||||
| Randomise participant | X | |||||||
| Administer treatment | X | |||||||
| Intermittent preventive treatment†† | X | X | X | |||||
| Laboratory procedures | ||||||||
| Capillary haemoglobin§ | X | X | X | X | X | X | X | X |
| Full blood count§ | X | X | X | X | X | |||
| Malaria diagnostics§‡‡ | X | X | X | X | X | X | ||
| Serum for iron markers tests§§ | X | X | X | X | X | |||
| Serum for inflammatory markers tests¶¶ | X | X | X | X | X | |||
| Phosphate | X | X | X | X | X | |||
| Adverse events§ | X | X | X | X | X | |||
| Morbidities | X | |||||||
| Missed visits§ | X | X | X | X | X | X | ||
| End of study | X | X | X | X | X | X |
*Since the opening of the trial, visits 3, 5 and 6 have been suspended since April 2020 due to the risk of exposing communities to COVID-19 during home visits.
†Visit conducted at the research site/health facility.
‡Visit conducted at the participant’s home.
§Protocol activities are also collected at any unscheduled visits.
¶Complete maternal physical examination includes general appearance, throat, neck, thyroid, musculoskeletal, skin, lymph nodes, extremities, pulses, pulmonary, cardiac, abdominal and neurological examination.
**Limited maternal physical examination includes general appearance, brief pulmonary, cardiac, abdominal and neurological examination.
††Assessing if intermittent preventive treatments sulphadoxine pyrimethamine and albendazole were given.
‡‡Malaria diagnostics include malaria rapid diagnostic test, malaria microscopy.
§§Serum for iron markers tests include serum ferritin.
¶¶Serum for inflammatory markers tests include C reactive protein and alpha-1 glycoprotein.