病史指征宫颈环扎联合阴道黄体酮预防单胎妊娠早产的疗效分析

Efficacy of history-indicated cerclage combined with vaginal progesterone in prevention of preterm birth in singleton pregnancy

关键词:  宫颈机能不全  病史指征宫颈环扎  阴道黄体酮  早产  妊娠结局

Key words:  cervical incompetence  history-indicated cerclage  vaginal progesterone  preterm birth  pregnancy outcome

摘要:

目的 探讨病史指征宫颈环扎联合阴道黄体酮预防单胎妊娠早产的临床疗效。方法 本研究为一项回顾性队列研究。选取2019年1月—2023年7月于上海交通大学医学院附属同仁医院和同济大学附属东方医院因病史指征行经阴道宫颈环扎术（Shirodkar术式）的宫颈机能不全单胎妊娠女性。纳入符合标准的研究对象共279例，完整收集孕妇的一般临床资料和母婴结局，并进一步根据术后是否使用阴道黄体酮分为单纯宫颈环扎组（130例）和宫颈环扎联合阴道黄体酮组（149例）。分析比较两组孕妇的一般临床资料、母体妊娠结局、新生儿结局。结果 两组妊娠37周前早产发生率差异无统计意义（P=0.592 3）。与单纯宫颈环扎组相比，宫颈环扎联合阴道黄体酮组分娩孕周[（266.59±16.02） d vs (259.23±30.81) d，P=0.011 4）]、环扎至分娩的间隔时间[（163.18±23.17） d vs (152.51±33.58) d，P=0.002]较长、妊娠28周前流产发生率较低（0.7% vs 7.7%，P=0.003 4）。两组新生儿结局包括出生体重、低体重儿、5 min Apgar评分<7分、入住NICU、新生儿并发症等方面的差异均无统计学意义（均P>0.05）。多因素Logistic回归模型分析潜在早产高危因素与早产发生率的关联，结果显示宫颈环扎术后是否联用阴道黄体酮与早产发生率并无相关性（OR=1.02，95%CI: 0.482.15，P=0.962），自发性早产史与早产发生风险增加有相关性。结论 病史指征宫颈环扎联合阴道黄体酮与妊娠28周前流产率降低相关，但在改善妊娠母儿结局方面并无优势。该结论仍有待在更大规模、更高质量的前瞻性研究中验证。

Abstract:

Objective To explore the clinical efficacy of history-indicated cerclage combined with vaginal progesterone for the prevention of preterm birth in singleton pregnancies. Methods The maternal data and infant outcomes of 279 singleton pregnant women with cervical insufficiency who underwent Shirodkar cervical cerclage surgery at Tongren Hospital and the Oriental Hospital from January 2019 to July 2023 were retrospectively reviewed. The subjects were further divided into two groups: 130 cases received cervical cerclage alone(control group) and 149 case received cervical cerclage plus vaginal progesterone(study group). General clinical data, maternal pregnancy outcomes, and neonatal outcomes were analyzed and compared between the two groups. Results There was no significant difference in the rate of preterm birth before 37 weeks between the two groups(P=0.592 3). Compared with the control group, the study group had a longer gestation period [(266.59±16.02) d vs (259.23±30.81) d, P=0.011 4], a longer interval from cerclage to delivery[(163.18±23.17) d vs (152.51±33.58) d, P=0.002], and a significantly lower rate of miscarriage rate before 28 weeks(0.7% vs 7.7%, P=0.003 4). There was no significant difference in neonatal outcomes between the two groups, including birth weight, low birth weight, Apgar score<7 at 5 min, NICU admission, and neonatal complications(all P>0.05). Multivariate logistic regression model showed that history of preterm birth was an independent risk factor of preterm birth(OR=4.23, 95%CI: 1.22-13.44, P<0.014), but vaginal progesterone use after cervical cerclage could not reduce the risk of preterm birth(OR=1.02，95%CI: 0.48-2.15，P=0.962）. Conclusion The use of vaginal progesterone after cervical cerclage for singleton pregnancy with a history of cervical incompetence may reduce miscarriage rate before 28 weeks, but it has no advantage in improving maternal and neonatal outcomes. This results still need to be verified in larger-scale and higher-quality prospective studies.