Methods | Randomized controlled trial. | |
Participants | Women referred to Department of Obstetrics and Gynecology with suspected PID with different degrees of severity (none, mild, moderate, and severe); 53% with mild degree of salpingitis. Inclusion criteria: history of lower abdominal pain < 3 weeks' duration, and presence of cervical motion tenderness, uterine and adnexal tenderness on bimanual examination. Exclusion criteria: use of antibiotics, had any gynaecological operation or instrumentation of the upper genital tract in the preceding month, had systemic disease or epilepsy, pregnant, suspected allergy to any of the drugs used, or puerperal infection. Number of women randomized: 40. Number of women analyzed: group A: 16; group B: 20. Number of withdrawal/exclusions/loss to follow‐up and reasons: 4 due to other diagnosis: toxoplasmosis, urinary infection, periappendicular abscess, no pathological findings. Number of centres: 1. Age (mean ± SD (range)) (years): group A: 29 ± 8 (18‐43); group B: 29 ± 1 (16‐50). Country: Finland. |
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Interventions |
Group A: ciprofloxacin 200 mg IV every 12 h for 2 days followed by 750 mg PO every 12 h to complete 14‐day course. Group B: doxycycline 100 mg IV every 12 h + metronidazole 500 mg IV every 8 h for the first 2 days, followed by doxycycline 150 mg PO every 24 h + metronidazole 400 mg PO every 8 h to complete a 14‐day course. |
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Outcomes |
Primary outcomes: clinical response based on a scale from 0 (absent or normal) to 3+ (severe) assessed on days 3, 6, 14, and 21 after the antimicrobial treatment was started. Failure defined as the presence of ≥ 1 of following criteria: no improvement in the clinical severity score at day 3 after the microbial treatment was started; CRP > 20 mg/L or a decline < 50% in the initial CRP level at day 6; positive cervical culture of N gonorrhoeae or C trachomatis at days 14 or 21; or the need for additional antimicrobial agents or surgical intervention. Secondary outcomes: adverse reactions and effects. |
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Notes |
Ethical approval: not stated. Informed consent: signed consent obtained. Source of funding: not stated. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated how randomization was done. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
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 | All women randomized were analyzed. |
Selective reporting (reporting bias) | Unclear risk | No trial protocol found. |
Other bias | Unclear risk | Not stated if all women were assessed 21 days after the antimicrobial treatment was started. |