University Hospital Sussex NHS Trust, Brighton BN2 5BE, United Kingdom.
Department of Women and Children's Health, King's College London, St Thomas' Hospital, United Kingdom.
Eur J Obstet Gynecol Reprod Biol. 2022 Sep;276:113-117. doi: 10.1016/j.ejogrb.2022.06.025. Epub 2022 Jun 30.
The ability to predict spontaneous PTB (sPTB) has improved greatly, allowing women at risk to be managed with prophylactic interventions such as cervical cerclage and the Arabin pessary. Cervicovaginal fetal fibronectin (qfFN) concentration and ultrasound measurement of cervical length (CL) are the two most established tools to predict sPTB. There is however limited data regarding the predictive value of qfFN and CL tests following insertion of an Arabin pessary. Our aim was therefore to determine the clinical use of qfFN and CL measurements to predict sPTB in women fitted with an Arabin pessary.
This study is a secondary analysis on the SUPPORT trial data. Data were prospectively collected from women attending high-risk preterm surveillance clinics in 3 London centres between July 2015 and April 2020. The matched control group was pregnant women attending the same high-risk preterm surveillance clinics who had not received an Arabin pessary. Receiver operating characteristic (ROC) curves for prediction of birth by 34 and by 37 weeks' gestation were generated for qfFN and CL measurements combined for both study groups. A formal comparison of area under the curve before 34 weeks' gestation (AUC < 34 weeks) was made between the two study groups.
At our primary endpoint of sPTB < 34 weeks' gestation, qfFN was a good predictor of sPTB in cases with an Arabin pessary in situ (AUC, 0.79, 95% CI: 0.62-0.90) and no worse than the control group who did not have an Arabin pessary, (AUC 0.74, 95% CI: 0.48-0.96). CL had good prediction for sPTB < 34 weeks' gestation in the control group (AUC 0.76, 95% CI: 0.63-0.88) but was lower and non-significant in the Arabin pessary case group (AUC 0.60, 95% CI: 0.43-0.76).
This study showed that cervicovaginal qfFN concentration is equally reliable in the prediction of sPTB in pregnant women at increased risk of sPTB with and without an Arabin pessary in situ, and significantly better than CL measurement alone for predicting delivery before 34 weeks. This commonly used test therefore has utility in predicting sPTB in pregnant women fitted with an Arabin pessary.
自发性早产（sPTB）的预测能力已经有了很大的提高，这使得有风险的妇女能够通过预防性干预措施进行管理，如宫颈环扎术和阿拉伯阴道塞。宫颈阴道胎儿纤维连接蛋白（qfFN）浓度和宫颈长度（CL）的超声测量是预测 sPTB 的两种最成熟的工具。然而，关于阿拉伯阴道塞置入后 qfFN 和 CL 试验预测 sPTB 的预测价值的数据有限。因此，我们的目的是确定 qfFN 和 CL 测量在接受阿拉伯阴道塞治疗的妇女中预测 sPTB 的临床应用。
本研究是对 SUPPORT 试验数据的二次分析。数据是从 2015 年 7 月至 2020 年 4 月期间在伦敦 3 个中心的高危早产监测诊所就诊的妇女前瞻性收集的。匹配的对照组是在同一高危早产监测诊所就诊但未接受阿拉伯阴道塞的孕妇。为两组研究生成了预测 34 周和 37 周妊娠时分娩的 qfFN 和 CL 测量的接收者操作特征（ROC）曲线。在两组之间比较了 34 周前（<34 周）的曲线下面积（AUC）。
在我们的主要结局 sPTB <34 周时，qfFN 是阿拉伯阴道塞在位情况下 sPTB 的良好预测因子（AUC，0.79，95%CI：0.62-0.90），并不比未接受阿拉伯阴道塞的对照组差（AUC 0.74，95%CI：0.48-0.96）。CL 对对照组 sPTB <34 周的预测良好（AUC 0.76，95%CI：0.63-0.88），但在阿拉伯阴道塞病例组中较低且无统计学意义（AUC 0.60，95%CI：0.43-0.76）。
本研究表明，在有和没有阿拉伯阴道塞在位的高危 sPTB 孕妇中，宫颈阴道 qfFN 浓度在预测 sPTB 方面同样可靠，并且明显优于单独的 CL 测量，用于预测 34 周前分娩。因此，这种常用的测试在预测接受阿拉伯阴道塞治疗的孕妇的 sPTB 方面具有实用性。
