Table 3.
Secondary outcomes at 6 weeks post-delivery based on data from questionnaire (intention-to-treat population)
| Amoxicillin and clavulanic acid (n=1296) | Placebo (n=1297) | Effect measure (99% CI) | p value | ||
|---|---|---|---|---|---|
| Perineal pain | 592 (46%) | 707 (55%) | 0·84 (0·76 to 0·93)* | <0·0001 | |
| Missing | 0 | 0 | NA | NA | |
| Use of pain relief for perineal pain | 99 (8%) | 138 (11%) | 0·72 (0·52 to 0·99)* | 0·0073 | |
| Missing | 13 | 18 | NA | NA | |
| Need for additional perineal care | 390 (31%) | 543 (43%) | 0·72 (0·63 to 0·83)* | <0·0001 | |
| Missing | 42 | 38 | NA | NA | |
| Wound breakdown | 142 (11%) | 272 (21%) | 0·52 (0·41 to 0·67)* | <0·0001 | |
| Missing | 4 | 7 | NA | NA | |
| Dyspareunia† | 299 (55%) | 280 (54%) | 1·01 (0·87 to 1·17)* | 0·873 | |
| Missing | 5 | 8 | NA | NA | |
| Breastfeeding at 6 weeks | 662 (51%) | 657 (51%) | 1·01 (0·91 to 1·11)* | 0·828 | |
| Missing | 4 | 4 | NA | NA | |
| Perineum ever too painful or uncomfortable to feed baby | 136 (11%) | 198 (17%) | 0·69 (0·53 to 0·90)* | <0·00025 | |
| Missing | 96 | 98 | NA | NA | |
| Hospital bed stay to discharge | 1 (1–2) | 1 (1–2) | 0 (0 to 0)‡ | 0·318 | |
| Missing | 0 | 0 | NA | NA | |
| Any primary care or home visits in relation to perineum | 361 (28%) | 496 (38%) | 0·73 (0·63 to 0·84)* | <0·0001 | |
| Missing | 3 | 5 | NA | NA | |
| Any outpatient visits in relation to perineum | 95 (7%) | 173 (13%) | 0·55 (0·40 to 0·75)* | <0·0001 | |
| Missing | 5 | 6 | NA | NA | |
| Maternal hospital re-admission | 63 (5%) | 84 (7%) | 0·75 (0·49 to 1·14)* | 0·072 | |
| Missing | 47 | 51 | NA | NA | |
| Maternal health-related quality of life | |||||
| EQ-5D-5L score | 0·935 (0·098) | 0·927 (0·111) | 0·008 (−0·003 to 0·019)§ | 0·048 | |
| Missing | 16 | 18 | NA | NA | |
Data are n (%), n, median (IQR), or mean (SD). NA=not applicable. EQ-5D-5L=five-level EuroQol-5D questionnaire.
*
Risk ratio (risk in amoxicillin and clavulanic acid group/risk in placebo group).
†
Denominator is all women who have attempted intercourse since giving birth (n=544 amoxicillin and clavulanic acid group, n=514 control group).
‡
Difference in medians for hospital bed stay to discharge.
§
Difference in means.