Hagglund 1989.
Methods | Randomized, placebo‐controlled trial; 2 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collections: July 1983 and December 1986. Setting: University Hospital, Lund, Sweden. Inclusion criteria: women undergoing emergency CS (during labor and/or after rupture of membranes [duration not specified]); categorized as "both" for this review. N = 160. Exclusion criteria: fever > 38oC, given antibiotics, chemotherapy or immunosuppressive therapy in prior 3 weeks, allergy to cephalosporins, alcohol or drug abuse, chronic disease of cardiovascular, renal, hepatic or gastrointestinal system, severe anemia. |
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Interventions |
Intervention:
Comparison: placebo:
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Outcomes | Endometritis (fever > 38oC twice at least 1 hr apart, after the 1st post‐operative day, and increased tenderness of the uterus); wound infection (redness, tenderness, increased heat and edema of wound); UTI. | |
Notes | There were no cases of septicemia or abscess formation observed in either group.
Only 55% of women had ruptured membranes (number > 6 hs not stated) and 77% were in labor; these definitions do not meet our criteria for non‐elective section, categorized as 'both'. Class of antibiotic: 2nd generation cephalosporin. Subgroups:
The 2 groups were comparable regarding age, parity, previous CS, complications during pregnancy and gestational age at the operation. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...a pre‐set randomized series in a double‐blind manner...". Comment: no description of sequence generation process. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no losses or exclusions were reported. It appears to be an ITT analysis. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind". Comment: placebo‐controlled (saline). |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information to judge. |
Other bias | Low risk | Comment: no other sources of bias identified. |