Stiver 1983.
Methods | Randomized, placebo‐controlled trial; 3 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collectin: no reported. Setting: 5 centers in Canada. Inclusion criteria: all women in labor or with ruptured membranes (duration of ruptured membranes not stated; mean duration 9.97 hrs; included in both category). N = 361. |
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Interventions |
Intervention 1: 1st generation cephalosporin:
Intervention 2: cefamycin:
Comparison: placebo:
Infused IV immediately after cord clamped and 6 and 12 hrs later. Results of both treatment groups combined. |
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Outcomes | Febrile morbidity (oral temperature > 37.9oC twice at least 6 hrs apart after 1st 24 hrs); wound infection (redness, induration, tenderness and/or purulent discharge from the incision line); endometritis/parametritis (uterine and/or adnexal tenderness with fever) UTI (dysuria or pyuria and positive culture); need for antibiotic therapy (11% for treatment groups vs 27% for placebo); maternal length of stay (7.3 and 7.4 days for treatment groups vs 7.9 for placebo). | |
Notes | Side effects documented: 2 infusion‐related hypotensive episodes (1 with cefazolin, 1 with placebo that necessitated withdrawal from study); 6 episodes of phlebitis (5 in treated, 1 in placebo group); 1 episode of angioedema (placebo patient). Data provided on antibiotic resistance in wound isolates and screening cervical cultures. 1 episode of bacteremia (in placebo group); 1 episode of septic shock (in cefazolin‐treated group); both outcomes included as serious morbidity.
Follow up at 6 weeks. Class of antibiotic: 1st generation cephalosporin or cefamycin (2nd generation cephalosporin). Subgroups:
The 3 groups were comparable regarding age, parity, gravidity, etc. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly assigned". 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: 7 women (1 in treatment, 6 in placebo group) initially randomized but results not included, 6 because they failed to receive all 3 doses, 1 because of hypotensive episode with 1st dose. As‐treated analysis performed. |
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. |