Methods | Randomized controlled trial. | |
Participants |
Inclusion criteria: women with PID associated or not associated with endometritis confirmed by laparoscopy according to the clinical criteria described by Hager and colleagues (Hager 1989). Exclusion criteria: known allergy to betalactamics, pregnant, renal and liver insufficiency. Number of women randomized: 82. Number of women analyzed: group A: 42; group B: 40. Number of withdrawals/exclusions/loss to follow‐up and reasons: 1 abandoned the amoxicillin‐clavulanic acid after knowing that the bacteria (K. pneumoniae) was resistant to the antibiotic. One stopped amoxicillin‐clavulanic acid after 6 days of treatment due to no clinical improvement and she was switched to group B; In group B, one patient stopped the treatment due to side‐effect (Quincke edema) Number of centres: 8. Age (mean (range)) (years): group A: 27.7 (18‐46); group B: 28.7 (15‐49). Country: France. |
|
Interventions |
Group A: amoxicillin‐clavulanic acid 1 g IV every 8 h for at least 48 h, then 1.5‐2 g PO twice daily. Mean length of treatment 19 days, never less than 14 days. Group B: amoxicillin 3‐4 g IV per 24 h, mean 4 days, then 1.5‐2 g PO daily. Mean length of treatment 17 days + aminoside (chosen by researcher's preference) 3‐5 mg/kg IM per 24 h 2 or 3 times daily depending of the aminoside, mean length of treatment 7 days + metronidazole 1 or 1.5 g IV or suppository daily. For each case, a secondary prescription for a tetracycline 200 mg per 24 h was given, either immediately if results of laparoscopy or other investigations justified it, or later on positive chlamydia serology. Length of this treatment 3‐4 weeks as decided by the researcher. |
|
Outcomes |
Primary outcomes: clinical cure; defined as absence of fever, pain, and previously observed adnexal masses at 5‐8 weeks' follow‐up; adverse events leading to discontinuation of treatment. Secondary outcome: none reported. |
|
Notes |
Ethical approval: not stated. Informed consent: not stated. Source of funding: not stated, and no conflicts of interest reported. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The choice of treatment fixed by randomization. |
Allocation concealment (selection bias) | Unclear risk | The choice of treatment fixed by randomization. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1/82 women lost to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | No protocol found. |
Other bias | Unclear risk | Not stated. |