| Methods |
Allocation by a coin‐flip table established at the beginning of the study. |
| Participants |
Women admitted for antepartum pyelonephritis, with an estimated average gestational age of 22 weeks at admission. The groups were well matched for age, race and temperature. Inclusion criteria: admission oral temperature of 38°C or greater, costovertebral angle tenderness, and a positive urine culture with 100,000 colony‐forming units/ml. Exclusion criteria: evidence of renal abscess, a prior episode of pyelonephritis during the index pregnancy, and women not exhibiting all the inclusion criteria. |
| Interventions |
Both groups received intravenous cephazolin only or cephazolin plus gentamicin or cephazolin plus other antibiotic or ampicillin plus gentamicin or other antibiotic (the initial antibiotic regimen was determined by the attending physician). In addition, the study group (n = 36) received nitrofurantoin 100 mg q.i.d. to complete 10 days of antibiotic therapy (intravenous followed by oral therapy). The control group (n = 31) received no further oral antibiotic therapy. No long‐term suppressive therapy was used in any of the participants. Women were removed from the study at the time of any positive urine culture or episode of recurrent pyelonephritis. |
| Outcomes |
Cure rates (intravenous antibiotics plus nitrofurantoin 34/36, intravenous antibiotics only 27/31); recurrent infection (intravenous antibiotics plus nitrofurantoin 6/36, intravenous antibiotics only 3/31). |
| Notes |
Charleston, North Carolina, USA. August 1990 to December 1994. Women were from a lower socioeconomic clinic population with about 1/3 of the women enrolled in the study not returning for their 2‐week culture check (9 women in the no oral therapy group and 8 women in the oral therapy group). Authors considered that this fact would call into question the compliance of women in the oral antibiotic treatment group, and that some of the early recurrent infections in the oral therapy group could represent women who were non‐compliant in completing their course of nitrofurantoin. However, the number of enrolled women that did not return was similar in both groups. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Coin‐flip table |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
|
