Methods | Randomized controlled trial. | |
Participants |
Inclusion criteria: aged > 16 years old; give written consent prior to entry; clinical diagnosis of acute PID made when woman had all following: lower abdominal tenderness, adnexal tenderness, and cervical motion tenderness; ≥ 1 of following: oral temperature ≥ 38.3 °C, abnormal cervical discharge, elevated ESR or CRP, and endocervical specimen positive for N gonorrhoeae or C trachomatis. Exclusion criteria: pregnant or lactation; history of hypersensitivity to penicillin, aminoglycoside, clindamycin, or metronidazole; severe hepatic disease; renal impairment (serum creatinine level > 2 mg/dL), or evidence of ruptured tubo‐ovarian abscess. Number of women randomized: 44; 22 in each group. Number of women analyzed: 44; 22 in each group. Number of withdrawals/exclusions/loss to follow‐up and reasons: 0 reported as lost to follow‐up. Number of centres: 1. Age (mean ± SD) (years): group A: 31.2 ± 9.1; group B: 24.9 ± 7.6. Country: Thailand. |
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Interventions |
Group A: (triple therapies) received intravenous therapy of 1 gm of ampicillin every 6 hours plus 5 mg/kg. (not exceed 240 mg) of gentamicin once daily and 500 mg of Metronidazole every 8 hours. Group B: clindamycin 600 mg IV every 8 h + gentamicin 5 mg/kg not exceeding a maximum dose of 240 mg once daily. In both groups, parenteral therapies continued until women were afebrile for minimum of 48 h then all women received a regimen of doxycycline 100 mg PO every 12 h to complete a 14‐day course. |
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Outcomes |
Primary outcomes: clinical cure; adverse events leading to discontinuation of therapy. Secondary outcome: length of hospital stay. Visual analogue scale on day 3 of treatment. |
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Notes |
Ethical approval: yes, approval for study obtained from the Ethical Committee of the Faculty of Medicine, Chulalongkorn University before trial was started. Informed consent: yes, all women gave written consent before entering into study. Source of funding: not stated, and no conflicts of interest reported. There were significant baseline imbalances between the 2 groups. Age, infertility, and severity of pain prior to this study significantly lower in group B (clindamycin/gentamicin). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization codes computer‐generated and sealed in envelope, then women were randomly assigned to 1 of the 2 regimens depending on their codes (A or B). |
Allocation concealment (selection bias) | Unclear risk | Not stated by whom allocation concealment was done. |
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. |