Characteristic | Oral metronidazole (n = 259) | Intravaginal lactic acid gel (n = 259) | Total (n = 518) |
---|---|---|---|
Age at randomisation (years) | |||
 Median [IQR] | 27 [23–34] | 27 [23–34] | 27 [23–34] |
Ethnicitya | |||
 White | 125 (48%) | 126 (49%) | 251 (48%) |
 Black Caribbean | 62 (24%) | 57 (22%) | 119 (23%) |
 Mixed Race | 24 (9%) | 27 (10%) | 51 (10%) |
 Black African | 26 (10%) | 15 (6%) | 41 (8%) |
 Indian, Pakistani or Bangladeshi | 7 (3%) | 9 (3%) | 16 (3%) |
 Other | 15 (6%) | 25 (10%) | 40 (8%) |
Vaginal douching in the past 3 monthsa | |||
 Yes | 36 (14%) | 25 (10%) | 61 (12%) |
 No | 223 (86%) | 233 (90%) | 456 (88%) |
Frequency of douching per month | |||
 0–2 | 9 (25%) | 6 (24%) | 15 (25%) |
 3–4 | 9 (25%) | 5 (20%) | 14 (23%) |
 5–6 | 1 (3%) | 3 (12%) | 4 (7%) |
 ≥ 7 | 17 (47%) | 11 (44%) | 28 (46%) |
Current use of oral contraceptive pilla | |||
 Combined oral contraceptive pill | 27 (10%) | 30 (12%) | 57 (11%) |
 Progesterone only pill | 18 (7%) | 14 (5%) | 32 (6%) |
 Contraceptive pill not currently used | 214 (83%) | 214 (83%) | 428 (83%) |
Past history of bacterial vaginosis | |||
 Approximate age when bacterial vaginosis first occurred (years)b | |||
  Median [IQR] | 22 [18–27] | 22 [19–27] | 22 [19–27] |
  Min, max | 14, 58 | 11, 50 | 11, 58 |
 Number of previous episodes of bacterial vaginosis in the past 12 months | |||
  0 | 3 (1%) | 3 (1%) | 6 (1%) |
  1–3 | 157 (61%) | 157 (61%) | 314 (61%) |
  > 3 | 99 (38%) | 99 (38%) | 198 (38%) |
 Approximate total length of time in past year with bacterial vaginosis symptomsa | |||
  < 2 weeks | 56 (22%) | 40 (15%) | 96 (19%) |
  ≥ 2 weeks and < 3 months | 135 (52%) | 130 (50%) | 265 (51%) |
  ≥ 3 months | 68 (26%) | 88 (34%) | 156 (30%) |
  Missing | 0 | 1 (< 0.5%) | 1 (< 0.5%) |
 Bacterial vaginosis confirmed at baseline visit (local laboratory)a | |||
  Yes | 217 (84%) | 219 (85%) | 436 (84%) |
  No | 31 (12%) | 29 (11%) | 60 (12%) |
  Not tested | 11 (4%) | 10 (4%) | 21 (4%) |
 Baseline sample Ison-Hay grade for bacterial vaginosis (central lab)c | |||
  0 (no bacteria) | 1 (< 0.5%) | 1 (< 0.5%) | 2 (< 0.5%) |
  1 (normal flora) | 48 (19%) | 62 (24%) | 110 (21%) |
  2 (intermediate bacterial vaginosis) | 62 (24%) | 61 (24%) | 123 (24%) |
  3 (confirmed bacterial vaginosis) | 138 (53%) | 128 (49%) | 266 (51%) |
  U (Gram positive cocci) | 3 (1%) | 1 (< 0.5%) | 4 (1%) |
  Missing | 7 (3%) | 6 (2%) | 13 (3%) |