Abstract:
The aim of the study was assessment of clinical effectiveness the cervical perforated pessary (CPP) used for prevention of preterm birth.
Eligible women were those referred to the institution for a diagnosis of cervical incompetence between 16 weeks and 18 weeks +6 days. The primary outcome will be PTL <37 weeks’ gestation for any indication. Secondary outcomes will be delivery before 28, 32 and 35 weeks of gestation; tocolytic drugs, antenatal corticosteroids or MgSO4 for neuroprotection use; preterm premature rupture of membrane; chorioamnionitis; maternal side effects (including vaginal discharge, fever, vaginal infection or pain, pessary repositioning and necrosis or rupture of the cervix); maternal morbidity (urinary tract infection, endometritis); birth weight; 5 min APGAR score; perinatal death, neonatal intensive care unit (NICU) admission; days of admission to the NICU; intraventricular hemorrhage; respiratory distress syndrome; necrotizing enterocolitis; neonatal infection and a composite of poor perinatal outcomes. The incidence of spontaneous preterm labor at less than 37 weeks of gestation was occurred in 9 patients (14,1%) from the pessary group and 17 participants (29,3%) in the control group (RR 0,48, 95% CI, 0,23-0,99, p=0,047). In generally, in the group of participants-carriers of CP we found a significantly lower rate of spontaneous preterm birth at less than 35 weeks of gestation (p=0,029), longer gestational age at delivery (p=0,002), higher birth weight (p=0,0005), higher rate by points APGAR score on 5 minutes (p=0,02), and lower incidence of adverse composite perinatal outcome (p=0,02) compared with patients from control group. In women-carriers of CP also were established significantly lower rates of respiratory distress syndrome (p=0,02). According to the adverse events follow-up, 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, p=0,04), but no significant differences in pelvic discomfort (RR 0,54, 95% CI, 0,14-2,18, p=0,39), chorioamnionitis (RR 0,30, 95% CI, 0,06-1,44, p=0,13), and endometritis (RR 0,68, 95% CI, 0,16-2,91, p=0,60) were reported. In our clinical prospective trial any cases of serious injuries cervix during removal of the CP were reported.
Conclusion. 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.
