Safety outcomes
| Cups (N=188) | Pads (N=256) | Controls (N=200) | Total (N=644) | |
|---|---|---|---|---|
| All severe adverse events | ||||
| Deaths recorded through HDSS | 0 | 0 | 0 | 0 |
| Participant identified to have symptoms of toxic shock syndrome | 0 | 0 | 0 | 0 |
| Visited health facility for toxic shock syndrome* | 0 | 0 | 0 | 0 |
| Other participant safety outcomes | ||||
| Referred for gynaecological check-up for heavy periods† | 5/188 (2.7%) | 5/256 (2.0%) | 0/186 (0.0%) | 10/644 (1.6%) |
| Prevalence of Staphylococcus aureus during follow-up | 17/177 (9.6%) | 27/214 (11.2%) | 21/186 (11.3%) | 65/604 (10.8%) |
| Prevalence of S. aureus at second survey of positives | 4/12 (25.0%) | 3/17 (17.6%) | 3/16 (18.8%) | 10/49 (20.4%) |
| Presence of toxic shock syndrome-1 toxin in S. aureus positive samples in second survey of positives | 0/4 | 2/3 | 0/3 | 2/10 |
*Registries of all health facilities reviewed.
†Eight (four cup, four pad) of the 10 cases had recorded heavy periods at baseline.
HDSS, Health and Demographic Surveillance System of all homesteads.