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 |