| Methods |
Randomized trial
Study period: July 1987 through April 1988 |
| Participants |
Inclusion criteria: women with diagnosis of postpartum endomyometritis defined as temperature greater than 100.4 °F (38 °C) on 2 occasions at least 6 hours apart or 101 °F (38.3 °C) once excluding the first postpartum day, uterine tenderness, leukocytosis, and absence of other foci of infection. Women with bacteremia were excluded
Setting: urban hospital, Tampa, Florida, USA
Number of participants: n = 109 |
| Interventions |
Oral ampicillin/clavulanic acid for 7 days following iv antibiotic therapy (clindamycin/tobramycin until afebrile for at least 24 hours; n = 37) vs no treatment following iv antibiotics (n = 72) |
| Outcomes |
Treatment failure
Need for additional antibiotic treatment (recurrent endometritis)
Costs were calculated was also evaluated and was a mean of USD 412 more in the oral antibiotic group |
| Notes |
There were 81 postcesarean births in this study
There were 2 control groups, 1 receiving iv antibiotics until 24 hours afebrile, the other receiving them until 48 hours afebrile. There was no difference between these 2 groups, and they are combined in this analysis
Pharmaceutical sponsorship ‐ explicit |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
States "randomized" 2:1, not further described |
| Allocation concealment (selection bias) |
Unclear risk |
No discussion of method of allocation |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
No mention of blinding/masking the participants, physicians or abstractors was noted |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
No mention of blinding/masking the participants, physicians or abstractors was noted |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
19 (14.8%) excluded from analysis with reasons shown in Table 1 of the manuscript |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol is not available, insufficient information to permit judgment |
| Other bias |
High risk |
Pharmaceutical sponsorship ‐ evident |
