| Methods |
Randomized trial
Study period: January 1989 through November 1989 |
| Participants |
Inclusion criteria: women postcesarean birth who had received a single 1 g dose of cefazolin during surgery with diagnosis of postpartum endometritis (defined as oral temperature of at least 101 °F (38.3 °C) > 24 postoperative hours and concomitant tachycardia, white blood count of at least 14,000 or a > 10% increase in immature leukocytes, and abnormal uterine tenderness)
Setting: Winston‐Salem, North Carolina, USA
Number of participants: n = 77 |
| Interventions |
Ampicillin 2 g plus sulbactam 1 g iv every 6 hours (n = 37) vs clindamycin 900 mg plus gentamicin 80 mg iv every 8 hours (n = 40) |
| Outcomes |
Therapeutic failure (defined as fever and no improvement in uterine tenderness after 72 hours treatment)
Diarrhea
Severe complications (septic pelvic thrombophlebitis, abscess) |
| Notes |
No oral antibiotics were given after discharge
There was a 6 week follow‐up period
All women were postcesarean birth with prophylactic antibiotics
Pharmaceutical sponsorship ‐ explicit |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computerized randomization schedule |
| 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 |
Drop‐outs ‐ none |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol is not available, insufficient information to permit judgment |
| Other bias |
High risk |
Pharmaceutical sponsorship ‐ evident |
