Stage 1982.
Methods | Design: randomised double‐blinded No. eligible: not stated No. randomised: unclear, but appears to be 284 (see drop‐outs/withdrawals below) No. analysed: 273 Drop‐outs/withdrawals: 11 from overall study (which included 199 caesarean section patients; data not in this review) due to incomplete records Years of recruitment: 1976 to 1978 Setting: 14 centres, United Stated |
|
Participants | Inclusion criteria: women having vaginal or abdominal hysterectomy (women having caesarean section ineligible; data not included in this review) Exclusion criteria: preoperative infection, allergy to study drugs. Age: mean 35 to 42 years Type of hysterectomy: abdominal or vaginal | |
Interventions | Treatment: 1 gram cephradine (first‐generation cephalosporin) Control: placebo Route: IV Single/multiple doses: multiple Timing of doses: first dose within 1 hour of surgery, second dose 4 hours later |
|
Outcomes | Postoperative infection, early Abdominal wound infection Urinary tract infection Adverse effects Need for therapeutic antibiotics Hospital length of stay (no SDs given) |
|
Funding | Not stated | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States that "each investigator was provided with an individually randomised block of patient numbers" |
Allocation concealment (selection bias) | Low risk | Method not reported |
Blinding (performance bias and detection bias) All outcomes | Low risk | States that "patients and investigators were blind to the allocation throughout the study" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Although proportion of withdrawals and reasons for withdrawal were not reported for each treatment group, total withdrawals constitute a small fraction of participants randomised (4%) |
Selective reporting (reporting bias) | Low risk | Data available on all prespecified outcomes |
Other bias | Low risk | Baseline demographic characteristics similar between treatment groups |