NATIONAL PIROGOV MEMORIAL MEDICAL UNIVERSITY, VINNYTSIA, UKRAINE.
OBSTETRICS, REGIONAL CLINICAL MATERNITY HOSPITAL, VITEBSK, BELARUS.
Wiad Lek. 2022;75(1 pt 2):191-196.
The aim: The assessment of clinical effectiveness the cervical perforated pessary (CPP) used for prevention of preterm labor.
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: 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).
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.
评估用于预防早产的宫颈穿孔避孕器(CPP)的临床效果。
材料和方法:2014 年至 2018 年,在文尼察第一妇产医院对既往有 SPL 的白人女性进行了随机分组,一组接受 CPP(临床组),一组不使用避孕器(对照组)。符合条件的女性是指在 16 周至 18 周+6 天期间因宫颈机能不全而转至该机构的女性。结局为 28 周前、32 周前、35 周前和 37 周前的早产;围产儿结局不良的复合结局。
结果:37 周前 SPL 的发生率为 14.1%,而对照组为 29.3%(RR 0.48,95%CI 0.23-0.99),35 周前 SPL 的发生率较低(RR 0.30,95%CI 0.10-0.88),妊娠期延长(差异-1.4,95%CI-2.30 至-0.50),出生体重增加(差异-197.9,95%CI-307.6 至-88.15),不良复合围产儿结局的发生率降低(RR 0.28,95%CI 0.1-0.81),分别来自避孕器组和对照组。与对照组相比,避孕器组的参与者阴道分泌物增多的发生率更高(RR 1.31,95%CI 1.01-1.69),但盆腔不适(RR 0.54,95%CI 0.14-2.18)和绒毛膜羊膜炎(RR 0.30,95%CI 0.06-1.44)无差异。
结论:既往有 SPL 的女性使用 CPP 可降低 SPL 的发生率。预防 SPL 策略成功的因素包括阴道微生物群的考虑和特殊培训人员在安装和护理宫颈避孕器方面的作用。