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. 2004 Apr 19;2004(2):CD003667. doi: 10.1002/14651858.CD003667.pub2

1. Characteristics of quasi‐randomised trials.

Study ID Methods Participants Interventions Results Notes
Siegel 1982 Allocated to one of two established regimens for prevention of gonococcal ophthalmia in alternating weeks during study period. 32058 infants born during period Dec1977 to May 1981. No birth weight or gestational age restrictions noted. Penicillin group (n = 16082) received penicillin G 50000 units I‐M if birth weight > 2000 g, or 25000 units I‐M if < 2000 g, within 1 hour of birth. Control group (n = 15967) received topical tetracycline ointment. Lower incidence of EOGBSD (0.2 vs 1.5 cases per 1000 live births, p < 0.001) and GBSD in penicillin group (0.6 vs 1.7 cases per 1000 live births, p = 0.004), non‐significant increase in disease due to penicillin‐resistant pathogens (2.2 vs 1.6 cases per 1000 live births, p = 0.32) and combined mortality (1.1 vs 0.7 per 1000 live births, p = 0.27) in penicillin group  
Gerard 1979 Infants born to mothers found to be GBS carriers allocated to 'immediate treatment' or 'late treatment' according to odd or even date of birth Vaginal culture performed on 1115 women; 76 (6.8%) carried GBS. Study group comprised of 67 of the 76 last trimester GBS positive mothers. (Cultures taken from ear canal, gastric aspirate and fetal side of placenta immediately following birth.) Immediate treatment (n = 29) received penicillin G 50000 to 100000 units/kg/day I‐M in two doses from delivery room, and continued for 7 days if any site positive. Late treatment (n = 38) received penicillin therapy only if cultures positive. 13 (45%) of 29 assigned to immediate treatment and 16 (42%) of 38 assigned to late treatment found to be colonised. No cases of systemic GBS disease in either group. No cases of late onset GBSD or side effects attributable to antibiotic therapy observed.  
Patel 1999 Allocated to receive penicillin prophylaxis or not in alternating blocks of 3 months for two years, then 2 month blocks for the third year. 10998 live births during study period Oct 92 to Sept 95. (8134 term, 2864 preterm) Penicillin prophylaxis group (n = 5389, 3989 term, 1400 preterm) received aqueous penicillin 50000 units I‐M within 1 hour of birth Lower incidence of the following outcomes in penicillin group: clinical sepsis (1.7% vs 2.5%, p < 0.01); identified sepsis (0.7% vs 1.2%, p < 0.01); GBSD (0.4% vs 0.9%, p < 0.001); GBS blood culture (0.11% vs 0.37%, p < 0.01); sepsis deaths (0.1% vs 0.3%, p < 0.01); and all deaths (0.5% vs 1.0%, p < 0.01). No identified adverse reactions, systemic or local, to penicillin. No increase in nosocomial infection rate and sepsis related to other pathogens. Maternal prophylaxis policy adopted four months into study period.