Dashow 1986.
Methods | RCT. Individual women. 5‐arm study. | |
Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Intervention 1: cephalosporin (B1).
Intervention 2: cephalosporin (B2).
Comparison: penicillin (A4).
4th group ‐ moxalactam disodium (1‐oxa‐beta‐lactam antibiotic: N = 64 in Table 4 (but 79 in Table 2). 5th group ‐ placebo (N = 77). Vitamin added to each solution for disguise. |
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Outcomes | Endometritis (temperature > 37.8 ºC, uterine tenderness, pelvic irritation without other localizing signs); wound infection (breakdown, positive culture and/or cellulitis): febrile morbidity (temperature > 100.4 x 2. 6 hour apart, excluded first 24 hours); mean duration of hospital stay. | |
Notes |
Dates: 1 December 1982 to 31 May 1984. Setting: Madigan Army Medical Center, US. Subgroups
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “A computer‐generated table of pseudo‐random numbers using the mixed congruential method was used by the pharmacy to assign each patient to one of five groups.” |
Allocation concealment (selection bias) | Low risk | “A computer‐generated table of pseudo‐random numbers using the mixed congruential method was used by the pharmacy to assign each patient to one of five groups.” |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | “Patients and physicians were unaware of the group assignment until after completion of the study...” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | “Patients and physicians were unaware of the group assignment until after completion of the study...” |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No explanation for differences between the numbers of the initially randomised groups and the groups included in the morbidity analysis (cephapirin 79 vs 70, cefamandole 70 vs 64, moxalactam 64 vs 79. The total of women included is the same (360); therefore we can assume that women originally assigned to one group received other treatment and they were not analysed by intention to treat. The uneven numbers may be due to lack of block‐randomisation. |
Selective reporting (reporting bias) | Unclear risk | We did not assess trial protocol. |
Other bias | Unclear risk | Baseline characteristics similar on: age; parity; gestation. Small difference on gravidity but not considered clinically important. However, other aspects of bias unclear. No information about funding source of study. |