| Methods |
Allocation by a computer‐generated random table. Assignments were placed in opaque, sealed envelopes. After a participant gave informed consent, the next envelope was opened to determine the treatment allocation. |
| Participants |
Pregnant women recruited from the emergency department of the hospital earlier than 24 weeks' gestation.
Inclusion criteria: one or more symptoms of UTI (temperature at least 100.4°F, flank pain, costovertebral angle tenderness) and urinalysis suspicious for UTI (7‐10 white blood cells per high‐powered field, 20 bacteria per high‐powered field, white blood cell casts, positive nitrites on urinary dipstick).
Exclusion criteria: women with history of allergy to the antibiotics being studied, had received antibiotic treatment within 2 weeks of enrolment, recurrent pyelonephritis, medical or other concurrent conditions that precluded enrolment, obvious sepsis, history of substance abuse or concurrent incarceration, nonviable or unwanted pregnancies, threatened abortion, inability to follow up because of geographic restrictions, or refusal to participate in the study. |
| Interventions |
Three groups.
First group (n = 62): 2 g ampicillin IV every 4 hours and gentamicin 1.75 mg/kg IV every 8 hours after an initial dose of 2 mg/kg IV gentamicin.
Second group (n = 58): 1 g IV cephazolin every 8 hours.
Third group (n = 59): two 1 g doses of ceftriaxone IM 24 hours apart, followed by 500 mg of oral cephalexin every 6 hours.
All participants received antibiotics and were hospitalised until they were non‐febrile for 48 hours. At discharge, all women were given 10‐day course of cephalexin 500 mg four times a day. Participants then were given nitrofurantoin 100 mg to take once a day for the remainder of their pregnancy and 6 weeks postpartum.
Women who failed to demonstrate significant improvement after 72 hours of therapy were reassessed. Decisions to change antimicrobial agents were made on individual basis. |
| Outcomes |
Cure rates (ampicillin plus gentamicin 58/62, cephazolin 55/58, ceftriaxone 1/59); recurrent pyelonephritis (ampicillin plus gentamicin 3/57, cephazolin 4/50, ceftriaxone 3/52); preterm delivery (ampicillin plus gentamicin 3/57, cephazolin 5/50, ceftriaxone 3/52); NICU admission (ampicillin plus gentamicin 9/57, cephazolin 11/50, ceftriaxone 12/52); antibiotic change required (ampicillin plus gentamicin 0/62, cephazolin 2/58, ceftriaxone 4/59); incidence of prolonged pyrexia (ampicillin plus gentamicin 6/62, cephazolin 4/58, ceftriaxone 6/59). |
| Notes |
Los Angeles, California, USA. October 1994 through May 1997. 189 participants (88.8%) returned for follow‐up examination. Urine cultures were obtained from 149 of these subjects. Authors concluded that IM ceftriaxone is as effective as IV ampicillin‐gentamicin and IV cephazolin in treating pyelonephritis in pregnancy before 24 weeks' gestation. The costs for the antibiotics would be 150.00 USD for ampicillin‐gentamicin and 75.00 USD for both cephazolin and ceftriaxone, but ceftriaxone can be given intramuscularly on an outpatient basis, and it could translate into substantial cost savings. Authors also noticed a low rate of preterm birth (6.9%) compared with the institutional and national rates (about 11%). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Computer‐generated random table. |
| Allocation concealment? |
Low risk |
Opaque, sealed envelopes. |
| Blinding?
All outcomes |
High risk |
Open‐label. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
|
| Free of other bias? |
Low risk |
|
