Fernandez 1990.
| Methods | Randomized trial Study period: March 1985 through March 1986 | |
| Participants | Inclusion criteria: fever (defined as more than 37.8 °C in the first 24 hours postpartum), with pelvic tenderness or malodorous lochia, or both, without other obvious diagnosis. Participants were classified as having mild (temperature 37.8 °C‐38.4 °C) or severe (temperature greater than 38.4 °C) forms Setting: Clamart, France Number of participants: n = 101 ("severe form": n = 26, "mild form": n = 73) | |
| Interventions | 'Severe' disease: amoxicillin/clavulanic acid 1.2 g iv every 8 hours (n = 14) versus ampicillin 2 g iv every 8 hours and gentamicin iv by body weight every 12 hours (n = 12) changing to oral amoxicillin/clavulanic acid or amoxicillin to complete 8 days treatment once afebrile "Mild" disease: oral treatment only amoxicillin/clavulanate (n = 36) vs ampicillin/metronidazole (n = 37) |
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| Outcomes | Treatment failure Mean time to defervescence (3.5 vs 2.7 days, not significant) Mean time to resolution of clinical signs of endometritis (2.3 vs 1.7 days, P value < 0.05) Duration of treatment Incidence of urticaria (allergic reaction) | |
| Notes | 2 women were excluded after enrolment (1 in each group) with culture demonstrating resistant Staphylococcus aureus Vaginal births = 62 Participants receiving both the iv and oral form of amoxicillin/clavulanic acid (Augmentin) have been combined Pharmaceutical sponsorship ‐ probable | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random‐number tables |
| 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 < 5% |
| Selective reporting (reporting bias) | Unclear risk | The protocol is not available, insufficient information to permit judgment |
| Other bias | Low risk | Study appeared to be free of other sources of bias |