Table 2.
Outcomes at 6 weeks post-delivery based on data from telephone follow-up and hospital records (intention-to-treat population)
| Amoxicillin and clavulanic acid (n=1715) | Placebo (n=1705) | RR* | p value | |||
|---|---|---|---|---|---|---|
| Confirmed or suspected maternal infection | 180 (11%) | 306 (19%) | 0·58 (0·49–0·69)† | <0·0001 | ||
| Missing | 96 | 99 | NA | NA | ||
| Confirmed systemic infection on culture | 11 (1%) | 25 (1%) | 0·44 (0·22–0·89)† | 0·018 | ||
| Missing | 1 | 1 | NA | NA | ||
| Endometritis | 15 (1%) | 23 (1%) | 0·65 (0·34–1·24)† | 0·186 | ||
| Missing | 1 | 1 | NA | NA | ||
| New prescription of antibiotics with relevant indication | 180 (11%) | 306 (19%) | 0·58 (0·49–0·69)† | <0·0001 | ||
| Missing | 96 | 99 | NA | NA | ||
| Systemic sepsis according to modified SIRS criteria for pregnancy | 6 (<1%) | 10 (1%) | 0·59 (0·16–2·24)‡ | 0·307 | ||
| Missing | 9 | 16 | NA | NA | ||
| Perineal wound infection | ||||||
| Superficial incisional infection | 75 (4%) | 141 (8%) | 0·53 (0·37–0·75)‡ | <0·0001 | ||
| Missing | 3 | 9 | NA | NA | ||
| Deep incisional infection | 36 (2%) | 77 (5%) | 0·46 (0·28–0·77)‡ | <0·0001 | ||
| Missing | 5 | 11 | NA | NA | ||
| Organ or space infection | 0 | 4 (<1%) | 0 | 0·044 | ||
| Missing | 7 | 11 | NA | NA | ||
Data are n (%), risk ratio (RR; 95% CI), or RR (99% CI). NA=not applicable. SIRS=systemic inflammatory response syndrome.
*
Risk in amoxicillin and clavulanic acid group/risk in placebo group.
†
95% CI.
‡
99% CI.