Saltzman 1985.
Methods | RCT; 2 parallel groups. | |
Participants | Dates of data collection: not specified. Setting: Fairfax Hospital, Virginia, US. Women predominantly private. Inclusion: criteria: high‐risk women undergoing CS (in active labor and/or ruptured membranes > 4 hrs); not consistent with the criteria for non‐elective in this review: classified as "both/undefined" in this review. Exclusion: active infection, fever, antibiotic use within 3 days, allergy to penicillin or cephalosporins. |
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Interventions |
Intervention: 3rd generation cephalosporin:
Comparison: placebo:
IV at time of cord clamping. |
|
Outcomes | Febrile morbidity (oral temperature > 37.9oC twice at least 8 hrs apart, after 1st 24 hr); endometritis (fever and foul lochia or uterine tenderness); UTI (fever and positive culture); wound infection (fever, abnormal‐looking wound, surrounded by cellulitis and/or draining purulent material). | |
Notes | There was 1 drug reaction (maculopapular rash) in the treatment group.
Women followed up at 6 weeks. Class of antibiotic: 3rd generation cephalosporin. Subgroups:
"The groups were comparable. No significant differences were observed between the 2 groups with respect to maternal age, parity, gestational age, duration of labor, duration of ruptured membranes or use of internal fetal monitoring. There were no significant differences regarding indication for CS". |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomized". Comment: no description of sequence generation process. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: 1 patient was removed from the study when she became febrile in the delivery room, not included in 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: double‐blind, placebo‐controlled. |
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. |