Bourgeois 1985.
Methods | RCT; 3 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: initiated March 1981. Setting: Charlottesville, Virginia, USA, almost all were indigent women. Inclusion criteria: both 'low risk' (labor < 6 hrs) and 'high risk' (> 6 hrs) women undergoing CS. N = 148 for this comparison. Exclusion criteria: allergy to penicillin or cephalosporin; antibiotic use within 7 days; antibiotics required for other reasons; pyrexia > 38oC; foul amniotic fluid. |
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Interventions |
Intervention:
Comparison 1: placebo:
Comparison 2: no treatment:
As the objective of this review is to compare antibiotic with no antibiotic, rather than the effect of irrigation, only the 1st 2 groups are compared (double‐blind comparison). |
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Outcomes | Metritis (pyrexia > 38oC twice 8 hrs apart, after 24 hrs plus abnormal uterine tenderness, without another apparent source); duration of maternal stay (treatment 5.29 days vs placebo 6.32 days, variance could not be calculated). | |
Notes | Authors' definition of low and high risk do not correspond to those used for elective/non‐elective in this review.
No treated patients developed evidence of drug reaction.
There were no serious infections (pelvic abscess or phlebitis) in either group. Class of antibiotic: 2nd generation cephalosporin. Subgroup:
The groups were comparable regarding gravidity, parity, maternal weight, hematocrit, etc. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A computer generated table of random numbers". |
Allocation concealment (selection bias) | Low risk | Quote: "Assigned under the direction of the hospital pharmacy". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no loss to follow‐up reported; no participants excluded; ITT analysis. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: partially double‐blind placebo‐controlled (3 groups: antibiotic irrigation, saline placebo irrigation, no irrigation). Physicians were unaware of the type of irrigation used. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: probably outcome assessment was blinded. |
Other bias | Low risk | Comment: no other sources of bias identified. |