Methods | Randomized controlled trial. | |
Participants |
Inclusion criteria: women with PID diagnosis based on all the following criteria: pelvic pain, either spontaneous or at palpation; cervical motion tenderness; and adnexal pain. Exclusion criteria: aged < 16 year, current pregnancy, allergy to 1 of the medications used in study or to penicillin, serum creatinine > 1.5 mg/dL, previous or current hepatic disease, use of antibiotics in the last 7 days, in situ IUD. Number of women randomized: 78. Number of women analyzed: 76; group A: 40; group B: 36. Number of withdrawals/exclusions/loss to follow‐up and reasons: 2, intolerance to penicillin. Number of centres: 1. Age (mean ± SD) (years): group A: 25.3 ± 7.7.4; group B: 29.4 ± 7.8. Country: Italy. |
|
Interventions |
Group A: gentamicin, 2 mg/kg IV (attack dose), followed by 1.5 mg/kg IV every 8 h + clindamycin 900 mg IV every 8 h for 4 days, followed by clindamycin 450 mg PO every 6 h for a total of 14 days of treatment. Group B: ceftazidime 1 g IV every 8 h + doxycycline 100 mg PO every 12 h for 4 days, followed by doxycycline 100 mg PO every 12 h for a total of 14 days of treatment. |
|
Outcomes |
Primary outcome: clinical recovery, defined as: body temperature < 37 °C per 48 h, disappearance of pelvic pain, no increase of eventual adnexal mass after 7 days of the end of treatment. Secondary outcome: follow‐up performed 30 days after treatment finished; endocervical culture for N gonorrhoeae and C trachomatis and endometrial culture for C Trachomatis performed in all positive cases at admission. |
|
Notes |
Ethical approval: not stated. Informed consent: not stated. Funding source: no funding stated or declaration of interest. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Women were randomly allocated into 2 treatment groups. |
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 | 2/78 women excluded from analysis. |
Selective reporting (reporting bias) | Unclear risk | Not stated. |
Other bias | Unclear risk | Not stated. |