| Methods |
Allocation by alternation, according to a "strict" admission order to received one or another treatment. Specific method of allocation not stated. |
| Participants |
Pregnant women between 12 and 34 weeks of gestation attending the Department of Obstetrics, Gynecology and Neonatology. Participants were admitted only during the morning of weekdays because of the availability of microbiological studies. 375 women with diagnosis of pyelonephritis were screened and 111 were enrolled (29.6%).
Inclusion criteria: acute pyelonephritis (fever greater then 38°C, chills, low back pain and urinary test with bacteria and leukocytes). A urine culture was used to confirm the diagnosis. Gestational age was determined by the menstrual history and the fetal biometric scan before 24 weeks of gestation. Exclusion criteria: use of antibiotics within 30 days before the start of the trial, another important disease, hypersensitivity and microorganism resistance to the antibiotic, impairment of renal function, clinical signs of sepsis and/or respiratory distress and fetal malformation. |
| Interventions |
CPD group 1 (n = 55): 1 g IV every 6 hours by 72 hours. Then 500 mg oral every 8 hours by 11 days to complete 14 days. CFX group 2 (n = 56) 750 mg IV every 8 hours by 72 hours, dissolved in glucose 5% solution 100 cc, perfunded in 20 minutes. CFX acetyl 250 mg oral was continued by 11 days to complete 14 days. If fever, bacteriemia at admission and/or vomiting persisted, IV treatment was prolonged by 5 days. If microorganism resistance or hypersensitivity to the drugs, the schedule was changed according to the sensitivity. After randomisation, absolute bed rest was prescribed, IV hydration, and control of main parameters and uterine contraction. |
| Outcomes |
Microbiological cure rate, clinical cure rate, recurrent infection, bacteriological failure rate, clinical cure failure. |
| Notes |
Department of Obstetrics, Gynecology and Neonatology, Santiago de Chile, Chile. April 1996 to February 1999. Six women (10.9%) were excluded from group 1 (CPD) and 4 participants (7.1%) from group 2 (CFX) after randomisation. 49 participants (89%) completed the protocol in group 1 and 52 (92.8%) in group 2. Reasons for exclusion: three loss to follow‐up, three because microbiological resistance to cephradine who were assigned to this group, one lethal fetal malformation, one failed to accomplish with treatment (no reasons stated), one low urinary tract infection, one dermatological reaction (rash) to cefuroxime. Intention to treat analysis not performed. Socio‐economic status of the population not stated. Authors conclude that, according the results of this study, CFX is a more efficient therapy that CPD, with similar costs. Funded by Glaxo‐Wellcome, manufacturer of Curocef (R). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
High risk |
Not done. |
| Allocation concealment? |
High risk |
Allocation by alternation, according to a "strict" admission order. |
| Blinding?
All outcomes |
High risk |
|
| Incomplete outcome data addressed?
All outcomes |
Low risk |
|
