高位与低位经阴道宫颈环扎的妊娠结局比较：C-STICH 试验二次分析
该研究为 C-STICH 多中心随机对照试验的二次分析，纳入 1995 例有环扎高度信息的早产高风险妊娠，比较高位于低位经阴道宫颈环扎的妊娠结局。结果显示两组妊娠丢失率相近，高位环扎与平均分娩孕周增加 0.5 周及 32 周前分娩率降低相关。
要点
- 高位与低位宫颈环扎的妊娠丢失率无显著差异。
- 高位环扎或使平均分娩孕周增加 0.5 周。
- 高位环扎与 32 周前分娩率降低相关。
核心结论
- 高位与低位经阴道宫颈环扎的妊娠丢失率无显著差异。
- 高位环扎可能与早产高风险女性的妊娠时间小幅延长及 32 周前早产减少相关。
研究设计与样本
- 该研究为 C-STICH 多中心随机对照试验的二次分析，纳入 1995 例有环扎高度信息的参与者。
- 研究地点为英国多家产科单位，研究对象为 C-STICH 试验中接受经阴道宫颈环扎的女性。
主要发现
- 1995 例有环扎高度信息的女性中，24% 接受高位环扎，76% 接受低位环扎。
- 两组妊娠丢失率相近，分别为 6.5% 和 7.3%；校正风险比为 0.88，95% CI 为 0.57–1.34。
- 高位环扎与平均分娩孕周增加 0.5 周相关。
- 高位环扎的 32 周前分娩率较低，校正风险比为 0.57，95% CI 为 0.37–0.86。
关键数值与推荐
- 妊娠丢失定义为流产和围产儿死亡，围产儿死亡包括死产或出生后 7 天内新生儿死亡。
- 高位于低位环扎的妊娠丢失率分别为 6.5% 和 7.3%；校正风险比 0.88，95% CI 为 0.57–1.34。
- 32 周前分娩的校正风险比为 0.57，95% CI 为 0.37–0.86。
临床怎么用
- 在早产高风险女性中，高位于低位环扎的妊娠丢失率相近，临床可结合技术条件选择。
- 若以延长孕周或减少 32 周前早产为目标，可考虑选择高位环扎技术。
局限性
- 该研究为随机对照试验的二次分析，环扎技术由临床医生偏好决定，可能存在选择偏倚。
- 原文未报告高位与低位环扎在其他次要母儿结局上的具体数值比较。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
ABSTRACT Objective To compare pregnancy outcomes following high versus low vaginal cerclage in women at high risk of preterm birth. Design Secondary analysis of a multi-centre randomised control trial. Setting Obstetric units across the UK. Sample Women participating in the C-STICH trial who received a transvaginal cerclage. Methods Cerclage height was classified as high (with bladder dissection) or low (without bladder dissection). Cerclage technique was determined by clinician preference. For each outcome, regression models were fitted adjusting for pre-specified prognostic variables. Main Outcome Measures The primary outcome was pregnancy loss defined as miscarriage and perinatal mortality (stillbirth or neonatal death within 7 days). Secondary maternal outcomes included miscarriage and previable neonatal death, stillbirth, gestational age at delivery, preterm pre labour rupture of membranes and sepsis. Secondary neonatal outcomes included early and late neonatal death and sepsis. Results Of the 2048 women randomised to C-STICH, 1995 had details of cerclage height available: 24% received a high and 76% a low vaginal cerclage. Pregnancy loss rates were similar between the groups (6.5% vs. 7.3%; adjusted risk ratio 0.88, 95% CI: 0.57–1.34). High vaginal cerclage was associated with an increase in mean gestational age of 0.5 weeks and a lower rate of births before 32 weeks (adjusted risk ratio 0.57, 95% CI: 0.37–0.86). Conclusion Pregnancy loss rates do not differ significantly between high and low vaginal cerclage techniques. High cerclage may be associated with a small prolongation of pregnancy in women at high risk of preterm birth and reduction in preterm births < 32 weeks.
引用
- BJOG：High Versus Low Transvaginal Cerclage and Pregnancy Outcomes: A Secondary Analysis of the C‐STICH Trial
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。