Table 2.
Summary of procedures
| Time | Source | Sample | Tests to perform | Storage requirements |
|---|---|---|---|---|
|
Postpartum period (Consent/ Assent A) |
Maternal venous blood |
5 ml EDTA for plasma |
ELISA and IHA |
Filter paper 4 °C Plasma/serum − 20 °C |
| 4–8 weeks postpartum | Home visit to provide consent to be randomized (Consent/Assent B) | |||
| Before randomization | Clinical assessment | |||
| 6 months postpartum | Randomization to BZN 30d/150 mg (intervention arm) or BZN 60d/300 mg (control arm) | |||
| Before treatment | Maternal venous blood | 5 ml | PCR | 10 ml blood-Guanidine 4 °C |
| Once a week | Monitoring adverse events | |||
| During treatment |
Maternal finger prick/ venous blood |
DBS | BZN concentration | Filter paper −20 °C |
| End of treatment | Maternal venous blood | 5 ml | PCR | 10 ml blood-Guanidine 4 °C |
| 10 months after treatment | Maternal venous blood | 5 ml | PCR | 10 ml blood-Guanidine 4 °C |