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. Author manuscript; available in PMC: 2014 May 27.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Sep 8;(9):CD007855. doi: 10.1002/14651858.CD007855.pub2
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
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.
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
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
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