| Methods |
Randomized trial
Study period: not stated |
| Participants |
Inclusion criteria: women with a diagnosis of postpartum endometritis by temperature elevation to 39 °C on 1 occasion or 38.5 °C on 2 occasions after delivery
Setting: Louisville, Kentucky, USA
Number of participants: n = 129 |
| Interventions |
Ampicillin 2 g plus sulbactam 1 g iv (n = 64) every 6 hours vs clindamycin 900 mg plus gentamicin by body weight iv every 8 hours (n = 65) |
| Outcomes |
Cure (disappearance of presenting signs and symptoms)
Improvement (partial alleviation of presenting signs and symptoms)
Failure (no significant effect of study drug therapy on presenting signs and symptoms)
Indeterminate (does not fit into any other category or unable to evaluate (n = 1 in clindamycin/gentamicin group)
Diarrhea (9 vs 8)
Length of hospital stay (9 vs 10 days; no variance given) |
| Notes |
13 women were excluded after enrolment for numerous reasons, generally protocol violations
The number of women who underwent cesarean birth versus vaginal birth is not described
Endometritis was poorly defined
Pharmaceutical sponsorship ‐ explicit |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
States "randomised" 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 |
116 women (89.9%) out of 129 women included in the analysis. 9 lost to follow up in the ampicillin/sulbactam group and 4 in the clindamycin/gentamicin group |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol is not available, insufficient information to permit judgment |
| Other bias |
High risk |
Pharmaceutical sponsorship ‐ explicit |
