宫颈托预防自发性早产的单中心前瞻性队列研究

Prevention of Spontaneous Premature Birth With Cervical Pessary:A Single-Center Prospective Cohort Study

目的 针对宫颈管短的单胎孕妇,比较宫颈托和阴道凝胶治疗预防早产的临床效果。方法 本研究为前瞻性队列研究。纳入2020年8月–2022年12月,四川大学华西第二医院收治的28孕周前超声提示宫颈管长度(cervical length,CL)≤25 mm的148名孕妇。根据治疗方案将孕妇分为宫颈托组(n=55)或孕激素两组(n=93)。以37孕周前自发性早产(包括流产)为主要结局指标;37、34、32、30、28孕周前早产(包括治疗性早产、自发性早产及流产)或34、32、30、28孕周前自发性早产(包括流产)、平均延长孕周、新生儿疾病和新生儿死亡为次要结局指标。对两组孕妇的妊娠结局、新生儿结局等进行比较统计学分析。结果 宫颈托组与孕激素组相比较,37、34、32、30、28孕周前早产发生率差异均无统计学意义。排除治疗性早产,37孕周前自发性早产发生率宫颈托组(23.6%)较孕激素组(41.9%)更低,且这种差异在两组间有统计学意义(P=0.024)。34、32、30、28孕周前自发性早产发生率差异无统计学意义。新生儿疾病发生率、出生后转新生儿科率和新生儿死亡率在两组之间差异均无统计学意义。多因素logsitic分析发现,相对于孕激素治疗,采用宫颈托是预防孕妇37孕周前自发性早产的保护因素。结论 孕中期宫颈管短的单胎孕妇使用宫颈托治疗预防自发性早产能够显著降低37孕周前的自发性早产发生率。

Objective To study and compare the clinical effects of cervical pessary and progesterone for preventing preterm birth in singleton pregnant women with a short cervical length(CL).Methods This study was a prospective cohort study.A total of 148 pregnant women with CL≤25 mm,as determined by ultrasound examination performed before 28 weeks of pregnancy,were included in the study.All subjects were admitted to West China Second Hospital,Sichuan University between August 2020 and December 2022.According to their treatment plans,the pregnant women were divided into a cervical pessary group(n=55)and a progesterone group(n=93).Spontaneous preterm birth before 37 weeks of pregnancy was defined as the main outcome index.Preterm birth(abortion)or spontaneous preterm birth(abortion)before 37,34,32,30,and 28 weeks of pregnancy,mean extended gestational age,neonatal morbidity,and neonatal mortality were the secondary outcome indicators.The pregnancy outcomes and the neonatal outcomes of the two groups were compared and statistically analyzed.Results There was no statistically significant difference in the incidence of preterm birth(including iatrogenic preterm birth,spontaneous preterm birth,and abortion)before 37,34,32,30,and 28 weeks between the cervical pessary group and the progesterone group.When iatrogenic preterm birth was excluded,the incidence of spontaneous preterm birth before 37 weeks was lower in the cervical pessary group(23.6%)than that in the progesterone group(41.9%),with the difference between the two groups being statistically significant(P=0.024).There was no statistically significant difference in the incidence of spontaneous preterm birth(including miscarriage)before 34,32,30,and 28 weeks.There was no statistically significant difference in the incidence of neonatal morbidity,the rate of transfer to the neonatal care unit after birth,and the neonatal mortality rate between the two groups.Multivariate logistic analysis showed that treatment with cervical pessary was a protective factor for spontaneous preterm birth before 37 weeks compared to progesterone therapy.Conclusion Using cervical pessary to prevent spontaneous preterm birth in singleton pregnant women with a short cervical length in the second trimester can significantly reduce the incidence of spontaneous preterm birth before 37 weeks.