Table 2.
Protocol activity | Visit 7 | Visit 8 |
Delivery+1 day | Day 28 postpartum±2 days | |
Location of visit | Research site* | Research site* |
Pregnancy outcome | X | |
Physical examination and anthropometry†‡ | X§ | X¶ |
Laboratory procedures | ||
Capillary haemoglobin | X** | |
Full blood count† | X** | X |
Malaria diagnostics†† | X** | X |
Serum for iron markers tests‡‡ | X** | X |
Vaccination and Vit A supplementation status | X | |
Adverse events† | X | X |
Morbidities | X | |
Missed visits† | X | |
End of study | X | X |
*Visit done at the research site/ health facility.
†Protocol activities are also collected at any unscheduled visits.
‡Anthropometry includes assessing the infant’s weight, length and head circumference.
§The complete physical examination includes general appearance, throat, neck, thyroid, musculoskeletal, skin, lymph nodes, extremities, pulses, pulmonary, cardiac, abdominal and neurological examination.
¶The limited examination includes general appearance, brief pulmonary, cardiac, abdominal and neurological examination.
**These assessments are collected via cord blood.
††Malaria diagnostics include malaria rapid diagnostic test, malaria microscopy, malaria filter paper for PCR and histology at delivery.
‡‡Serum for iron markers tests include serum ferritin.