Methods | Randomized controlled trial. | |
Participants |
Inclusion criteria: women admitted to the University Hospital of the University of Medicine and Dentistry of New Jersey from February 1987 to October 1988 with the diagnosis of either postpartum endometritis or acute salpingitis. Diagnosis of uncomplicated PID was based on the clinical criteria described by Hager and colleagues (Hager 1989). Exclusion criteria: history of allergy to the study drugs or received any antibiotic in the 2‐week period prior to the study (exclusive of prophylactic antibiotics for caesarean delivery). Number of women randomized: 25 for PID Number of women analyzed: group A: 10; group B: 15. Number of withdrawals/exclusions/loss to follow‐up and reasons: .none Number of centres: 1. Age (years): group A: 23.2; group B: 23.2. Country: US. |
|
Interventions |
Group A: ciprofloxacin 300 mg IV every 12 h; treatment continued for 3‐5 days until the woman was asymptomatic for 24 h. Upon discharge from hospital, women received oral antibiotics to complete 10‐14 days of ciprofloxacin 750 mg PO twice daily. Group B: clindamycin 900 mg IV every 8 h + gentamicin 1.5 mg/kg IV every 8 h. Upon discharge from the hospital, the women received oral antibiotics to complete 10‐14 days of clindamycin 450 mg PO every 6 h. |
|
Outcomes | Primary outcome: treatment success, defined as women asymptomatic for 24 h. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Women randomly assigned to receive clindamycin + gentamicin or ciprofloxacin intravenously. |
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 | 25 women with uncomplicated PID randomized. 10 women received ciprofloxacin and 15 women received clindamycin + gentamicin. 1 woman prescribed clindamycin + gentamicin was not available because triple therapy was initially started. This woman was included in the analysis as treatment success. The authors did not clarify that. |