Methods |
Randomized trial
Study period: February 1981 through December 1982 |
Participants |
Inclusion criteria: diagnosis of postcesarean endometritis based on oral temperature of at least 100.4 °F (38 °C) after the first 24 hours postpartum, uterine tenderness and absence of other foci of infection
Setting: urban university hospital, New Jersey, USA
Number of participants: n = 124 |
Interventions |
Ceftizoxime 2 g‐3 g iv every 8‐12 hours (n = 68) vs cefoxitin 2 g every 12 hours iv (n = 24) vs clindamycin 600 mg iv every 6 hours with gentamicin 60 mg‐80 mg iv every 8 hours (n = 32) |
Outcomes |
Treatment failure
Diarrhea
Septic pelvic thrombophlebitis
Thrombophlebitis |
Notes |
It is not stated whether any of these women received prophylactic antibiotic treatment during surgery
Pharmaceutical sponsorship ‐ probable. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
States "randomly assigned" without further description |
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 |
12 women initially randomized excluded from analysis with excessive loss (10 women) in cefoxitin group. Cefoxitin group not included in analysis |
Selective reporting (reporting bias) |
Unclear risk |
The study protocol is not available, insufficient information to permit judgement |
Other bias |
Unclear risk |
The study appears to be free of other sources of bias, but pharmaceutical support is suspected |