Methods |
Randomized trial
Study period: January 1982 through November 1984 |
Participants |
Inclusion criteria: women with postpartum endometritis (meeting 2 of the following criteria: temperature at least 101 °F (38.3 °C), uterine tenderness, foul‐smelling lochia)
Setting: Boston, Massachusetts, USA
Number of participants: n = 50 |
Interventions |
Ampicillin 3 g iv every (n = 25) vs cefotaxime 2 g iv every 6 hours (n = 25) |
Outcomes |
Clinical cure or improvement
Pelvic abscess
Length of stay |
Notes |
13 vaginal births evenly distributed between groups
5 of the 7 women who failed treatment had received cefoxitin prophylaxis at the time of cesarean birth
Pharmaceutical sponsorship ‐ probable |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
States “randomly assigned” in abstract but no further detail description available |
Allocation concealment (selection bias) |
Unclear risk |
Not stated |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
States “All doses were blinded to participants, study personnel, physicians, and nursing staff.” |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
States “All doses were blinded to participants, study personnel, physicians, and nursing staff.” |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
45 (90%) analyzed |
Selective reporting (reporting bias) |
Unclear risk |
The protocol is not available, insufficient information to permit judgment |
Other bias |
Low risk |
Study appeared to be free of other sources of bias |