Methods | RCT. | |
Participants | 65 women included in the analysis (100 randomized, 24 excluded before treatment commenced, a further 11 were lost to follow up) Pregnant women consulting the hospital with at least 100,000 cfu/ml bacteria in urine culture were included The following women were excluded: (a) those with a known hypersensitivity to the penicillins; (b) those with infections caused by organisms resistant to the allocated drug; and (c) women already taking an antibiotic or who had taken one since providing the initial midstream urine |
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Interventions | Group 1: 400 mg of pivmecillinam 4 times daily for 7 days. Group 2: ampicillin 500 mg 4 times a day for 7 days. |
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Outcomes | Primary outcomes: Symptomatic infection: not reported. Persistent infection: at 2 weeks: group 1: 4/33 (12%); group 2: 4/32 (12.5%). Recurrent infection: at 2 weeks: group 1: 3/33 (9%); group 2: 2/32 (6.25%). Shift to another antibiotic: not reported. Adverse effects: those noted are: anorexia/vomiting, stopped treatment prematurely, diarrhea, headache, indigestion, pruritus ani, felt unwell, epigastric fullness, dizzy and light headed Secondary outcomes: Preterm delivery: not reported. 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: Relapse (infection with the same organism): at 6 weeks: group 1:9/25 (36%); group 2: 7/29 (24,1%). Change in liver function tests: results are unclear since some of the women had deranged values before treatment |
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Notes | The study had a second part where in patients were given lower dose of pivmecillinam. Only the first part, where the patients were randomized between the 2 treatments, was included in this meta-analysis |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Sequence generation was not described. “Randomized in equal numbers.” |
Allocation concealment? | Unclear | It was not described. |
Blinding? Participant |
Unclear | It was not stated. |
Blinding? Clinician |
Unclear | It was not stated whether the 1 administering the treatment was aware of the kind of treatment being given |
Blinding? Outcome assessor |
Yes | Patients were asked for their symptoms by doctors who were unaware of the treatment |
Incomplete outcome data addressed? All outcomes |
No | There were missing data from 11/76 patients who commenced treatment. (It appeared that 100 were randomized but that 24 were excluded before treatment commenced as bacteriuria was not confirmed from a second specimen) |
Free of selective reporting? | Yes | All of the outcomes were reported. |
Free of other bias? | Yes |