Pietrantoni 1998.
| Methods | Randomized trial Study period: not stated | |
| Participants | Inclusion criteria: women clinically diagnosed as having postpartum endomyometritis; the presence of fever (102.2 °F/39 °C), pelvic pain, and foul lochia Setting: Lousiville, USA Number of participants: n = 19 | |
| Interventions | Oral therapy using ofloxacin 400 mg every 12 hours plus clindamycin 900 mg every 8 hours until 24 hours afebrile vs clindamycin 900 mg iv every 8 hours plus gentamicin iv 5mg/kg/day every 8 hours until afebrile "Antibiotic therapy was continued for at least 48 hours unless significant clinical deterioration occurred necessitating the withdrawal of the patient from the study." |
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| Outcomes | Treatment failure | |
| Notes | This study was a preliminary study that enrolled 19 women towards the overall enrolment of 60 women for statistical significance There is no publication or report found after this publication Pharmaceutical sponsorship ‐ none apparent Information on number of cesarean births and vaginal births were not given |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | States "randomised" in the title and objective without further description |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | The interventions were evident, although the outcomes would not have been affected by a lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) All outcomes | High risk | There was no reason stated for 3 (16%) women loss to follow‐up; since n = 19, the loss of 3 women could certainly affect the outcome |
| Selective reporting (reporting bias) | Unclear risk | No protocol available. Only 1 outcome exists in the results |
| Other bias | Unclear risk | This study was a preliminary study that enrolled 19 women towards the overall enrolment of 60 women for statistical significance. However, we could not find any relevant reports or publications that followed this publication. There is a possibility that the trial stopped early due to some data‐dependent process |