| Methods |
Randomized trial
Study period: not stated |
| Participants |
Inclusion criteria: women with a diagnosis of postpartum endometritis defined as temperature of at least 38.3 °C occurring 24 hours after the administration the last dose of cefazolin, tachycardia, a white blood count of at least 14,000 or immature polymorphonuclear leukocytes, and marked uterine tenderness
Setting: Houston, Texas, USA
Number of participants: n = 170 |
| Interventions |
Ticarcillin/clavulanic acid 3.1 g iv every 6 hours (n = 85) vs clindamycin 900 mg iv every 8 hours and gentamicin iv dosed by body weight every 8 hours (n = 85) |
| Outcomes |
Therapeutic failure (lack of resolution of all signs and symptoms of infection resolved within 72 hours)
Length of hospital stay |
| Notes |
All participants had cesarean births with 3 doses of prophylactic cefazolin
18 women were excluded after enrolment for protocol violations
Pharmaceutical sponsorship ‐ explicit
All participants without clinical cure at 72 hours responded with the addition of ampicillin iv
Bacteriologic studies were performed |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
States “a computer‐generated randomisation schedule provided by Miles Pharmaceuticals.” |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Different treatments had different intervals between treatments suggesting the personnel would have known which treatment plan each patient was on. Insufficient information to make judgment for patients |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not stated |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
18 women (10.6%) were excluded after enrolment for protocol violations
“Ten women who received ticarcillin/clavulanic acid and eight in the clindamycin‐gentamicin group were disqualified for not fulfilling the criteria of the study protocol” – incomplete data are well‐balanced, small amount compared with the amount of data, and the reason for missing data is unlikely to be related to true outcome |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol is not available, insufficient information to permit judgement |
| Other bias |
High risk |
Pharmaceutical sponsorship ‐ explicit ‐ Miles Pharmaceuticals |
