Thomsen 1987.
Methods | Randomised, placebo‐controlled trial; 2 parallel groups | |
Participants | Inclusion: positive midstream urine culture for group B streptococcus at 27 to 31 weeks' gestation Setting: University Hospital, Denmark Number of participants: N = 69 |
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Interventions | Penicillin 10 million IU 3 times a day x 6 days, retreated if repeat cultures positive (N = 37) or placebo tablets (N = 32) | |
Outcomes | Preterm birth (< 37 weeks' gestation) Mean gestational age (39.6 weeks in treatment group (N = 37) vs 36.2 weeks in placebo group (N = 32)) |
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Notes | All mothers positive for group B streptococcus at delivery and their babies were treated with antibiotics Dates of study: October 1984 to October 1986 Funding sources: Leo Pharmaceutical Products (tablets); Nunc, Denmark (equipment) Declarations of interest: none reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as "randomly allocated" but no description of sequence generation process |
Allocation concealment (selection bias) | Unclear risk | Method of concealment of allocation not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Placebo‐controlled, described as "double‐blind" but no additional details provided |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Described as "double blinded" but no specific information provided to ensure outcome assessment was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Unclear risk | Insufficient information provided |
Other bias | Low risk | The study appears to be free of other sources of bias. |
Overall Risk of Bias | Unclear risk | Overall unclear |