Battarino 1988.
Methods | RCT; 3 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: not stated. Detting: Cerignola, Italy. Inclusion criteria: women in labor and/or with ruptured membranes (mean duration of ruptured membranes 10 hrs), classified as both elective and non‐elective in this review. Exclusion criteria: not stated. |
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Interventions |
Intervention 1:
Intervention 2:
Intervention 3:
As both treatments are classified as 3rd generation cephalosporins, the 2 treatment groups have been combined in the analysis. |
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Outcomes | Febrile morbidity (2 or more readings ≥ 38°C at least 6 hrs apart after the 1st 24 hrs after surgery; endometritis (pain accompanied by fever, with or without purulent discharge from the vagina); wound infection (redness, induration, pain on palpation and purulent discharge); UTI (dysuria, pyuria and urine culture > 106 bacteria/mL); septic shock (classified as serious maternal infection); maternal stay (7.3 days for ceftriaxone group vs 7.4 days for cefotaxime vs 8.7 days for control group; variance not provided); additional antibiotics (11.3% vs 10% vs 27.2% for the 3 groups respectively). | |
Notes | Translated from Italian. The authors' definition of non‐elective does not match those used in this review (included patients whose indication for CS was prior cesarean and fetal‐pelvic disproportion). Class of antibiotic: 3rd generation cephalosporin. Subgroups:
There were no significant differences among the groups for age, parity, gestation, indication for cesarean section, duration of membrane rupture, duration of labor or number of vaginal examinations. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "At random". 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: no loss to follow‐up reported (no explanation for small differences in numbers in each study group); no participants excluded; ITT analysis performed. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "placebo‐controlled". Comment: no additional details provided to judge. |
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. |