Methods | Quasi-randomized, alternate allocation. | |
Participants | 160 pregnant women who consulted in Simpson Memorial Maternity Pavilion from January, 1963 to April 1966 with bacteriological counts of 100,000/ml of urine were included | |
Interventions | Group 1:cycloserine 250 mg twice a day for 14 days. Group 2: sulphadimidine 500 mg 4 times a day for 14 days. |
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Outcomes | Primary outcomes: Symptomatic infection: group 1: 13/82; group 2:20/78. Persistent infection: group 1: 17/82; group 2: 39/78. Recurrent infection: group 1: 15/82; group 2: 16/78. Shift to another antibiotic: not reported. Adverse effects: Nausea: not reported. Headache: not reported. Flatulence: not reported. Others: not reported. Secondary outcomes: Preterm delivery: not compared between Cycloserine and Sulphadimidine Preterm labor: not reported. Neonatal infection: not reported. RDS in the neonate: not reported. Admission to NICU: not reported. Duration of neonatal respiratory support: not reported. Other outcomes: none. |
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Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | No | Alternate allocation was used. |
Allocation concealment? | No | Alternate allocation was used. |
Blinding? Participant |
No | 1 antibiotic was given twice and day and the other was given 4 times a day |
Blinding? Clinician |
No | The 2 antibiotics were administered in different ways. |
Blinding? Outcome assessor |
Unclear | Not stated. |
Incomplete outcome data addressed? All outcomes |
No | There were 160 patients included in the part of the study that compared cycloserine and sulphadimidine. The results of all 160 patientswere accounted for. However, therewas also mention of 6 patients who were treated but withdrawn in the study. The results in these 6 patients were not available |
Free of selective reporting? | Yes | |
Free of other bias? | Yes |
cfu: colony-forming units
NICU: neonatal intensive care unit
NS: not specified
RCT: randomized controlled trial
RDS: respiratory distress syndrome
UTI: urinary tract infection