Methods | Randomized controlled trial. | |
Participants |
Inclusion criteria: severe acute PID with peritonitis, tubo‐ovarian abscess, endometritis, and pelvic cellulitis. Exclusion criteria: not stated. Number of women randomized: 39; group A: 20; group B: 19. Number of women analyzed: 39; group A: 20; group B: 19. Number of withdrawals/exclusions/loss to follow‐up and reasons: not stated. Number of centres: not stated. Age (years): not stated. Country: not stated. |
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Interventions |
Group A: sulbactam 1 g + ampicillin 2 g IV every 6 h. Group B: metronidazole 15 mg/kg loading followed by 7.5 mg/kg IV every 6 h and gentamicin 1.5 mg/kg IV every 8 h. Antibiotics in both groups continued for minimum of 5 days. |
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Outcomes | No relevant outcomes reported for our analysis because the outcomes were not separately reported for the different diagnoses within the study groups. Authors stated clinical cure occurred in 19/20 women in group A and 16/19 women in group B. | |
Notes |
Ethical approval: not stated. Informed consent: not stated. Source of funding: not stated, and no conflicts of interest reported. 2 cases of posthysterectomy pelvic cellulitis were included in the analysis. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Non‐blinded study. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Non‐blinded study. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All women randomized were analyzed. |
Selective reporting (reporting bias) | Unclear risk | No trial protocol found. |
Other bias | Unclear risk | Not stated. |