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宫颈托预防自发性早产的多中心前瞻性研究

Multicenter Prospective Cohort Study of Cervical Pessary for Preventing Spontaneous Preterm Birth

    摘要
  • 摘要:
    目的  比较宫颈托与孕激素凝胶预防宫颈缩短所致自发性早产的作用。
    方法  采用多中心前瞻性队列研究设计，纳入2020年8月—2023年6月于中国六家医院收治的609例孕13～28周宫颈长度≤25 mm的孕妇，分为宫颈托和孕激素干预组。对比分析两组妊娠及新生儿结局。
    结果  总体孕妇中，单因素分析发现宫颈托组较孕激素组延长孕周更长（（70.98±36.43） d vs. （56.68±33.91） d，P<0.0001），<34周及<37周早产率、<37周自发性早产率更低（P<0.05），多因素分析示宫颈托组延长孕周更长（β=－11.02，95%置信区间（CI） －15.89～－6.15），<34周早产风险更低（优势比（OR）=1.908，95%CI 1.209～3.010）；单胎孕妇中，单因素分析发现宫颈托组较孕激素组延长孕周更长（（77.16±37.71） d vs. （67.34±36.64） d，P=0.010），<28周早产率及<28周自发性早产率均更低（P<0.05），新生儿出生体重及1 min、5 min Apgar评分均改善（P<0.05），多因素分析发现两组早产发生、延长孕周、新生儿结局差异无统计学意义（P>0.05）；双胎孕妇中，单因素分析发现宫颈托组延长孕周长于孕激素组（（56.02±28.15） d vs. （42.78±23.73） d，P<0.001），但<28周和<32周自发性早产率反而更高（P<0.05），多因素分析发现宫颈托组延长孕周更长（β=－17.40，95%CI －24.99～－9.81），<34周早产更低（OR=5.136，95%CI 2.246～11.744）。
    结论  对于宫颈长度≤25 mm的孕妇，宫颈托相较于孕激素可有效延长孕周，并可减少34周前的早产发生。

     

    Abstract:
    Objective  To compare the efficacy of cervical pessary versus vaginal progesterone gel in preventing spontaneous preterm birth in individuals with a short cervix.
    Methods  This multicenter prospective cohort study enrolled 609 pregnant women with cervical length ≤25 mm at 13-28 weeks of gestation from six hospitals in China between August 2020 and June 2023. Participants were divided into the cervical pessary group and the progesterone group. Maternal and neonatal outcomes were compared between the two groups.
    Results  In the overall population, univariate analysis showed that the cervical pessary group had a longer gestational prolongation (70.98 ± 36.43 d vs. 56.68 ± 33.91 d, P < 0.0001), and lower rates of preterm birth < 34 weeks, < 37 weeks, and spontaneous preterm birth < 37 weeks (P < 0.05). Multivariate analysis indicated that the cervical pessary group had longer gestational prolongation (β =－11.02, 95% CI －15.89 to －6.15) and a lower risk of preterm birth < 34 weeks (odds ratio OR = 1.908, 95% CI 1.209-3.010). In singleton pregnancies, univariate analysis revealed that the cervical pessary group had longer gestational prolongation (77.16 ± 37.71 d vs. 67.34 ± 36.64 d, P = 0.010), lower rates of preterm birth < 28 weeks and spontaneous preterm birth < 28 weeks (P < 0.05), as well as higher neonatal birth weight and better Apgar scores at 1 and 5 minutes (P < 0.05). However, multivariate analysis showed no significant differences between the two groups in preterm birth endpoints, gestational prolongation, or neonatal outcomes (P > 0.05). In twin pregnancies, univariate analysis showed that the cervical pessary group had longer gestational prolongation( 56.02 ± 28.15 d vs. 42.78 ± 23.73 d, P > 0.001), but paradoxically higher rates of spontaneous preterm birth < 28 weeks and < 32 weeks (P < 0.05). Multivariate analysis demonstrated that the cervical pessary group had longer gestational prolongation (β = －17.40, 95% CI －24.99 to －9.81) and a lower risk of preterm birth < 34 weeks (OR = 5.136, 95% CI 2.246-11.744).
    Conclusion  For pregnant women with a cervical length of ≤ 25 mm, cervical pessary is more effective than progesterone in prolonging gestation and can reduce the incidence of preterm birth before 34 weeks.

     

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