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OBJECTIVE The aim: The assessment of clinical effectiveness the cervical perforated pessary (CPP) used for prevention of preterm labor. PATIENTS AND METHODS Materials and methods: Caucasian women with prior SPL who were randomized to receive a CPP (clinical group) or without pessary (control group) was conducted at the Vinnytsya maternal hospital №1, from 2014 through 2018. Eligible women were those referred to the institution for a diagnosis of cervical incompetence between 16 weeks and 18 weeks +6 days. Outcomes will be PTL before 28, 32, 35, and 37 weeks of gestation; a composite of poor perinatal outcomes. RESULTS Results: The incidence of SPL at less than 37 weeks of gestation was occurred in 14,1% vs 29,3% (RR 0,48, 95% CI, 0,23-0,99), lower rate of SPL at less than 35 weeks of gestation (RR 0,30, 95% CI, 0,10-0,88), longer gestational age (Dif. -1,4, 95% CI, -2,30 to -0,50), higher birth weight (Dif. -197,9, 95% CI, -307,6 to -88,15), lower incidence of adverse composite perinatal outcome (RR 0,28, 95% CI, 0,1-0,81) from the pessary and control group respectively. The participants pessary clinical group had a higher rate than the control group of increased vaginal discharge (RR 1,31, 95% CI, 1,01-1,69), but no differences in pelvic discomfort (RR 0,54, 95% CI, 0,14-2,18), chorioamnionitis (RR 0,30, 95% CI, 0,06-1,44). CONCLUSION Conclusions: The women with prior SPL use of a CPP, resulted in a lower rate of SPL. The component in the successful results of preventive strategy SPL is consideration of vaginal microbiota and role of special trained staff for installation and care cervical pessary.