Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Obstetrix Medical Group, Seattle, WA, USA.
J Matern Fetal Neonatal Med. 2020 Aug;33(15):2628-2634. doi: 10.1080/14767058.2018.1555816. Epub 2019 Jan 7.
To determine if quantitative fetal fibronectin (qFFN) in addition to transvaginal ultrasound (TVU) cervical length (CL) measurement between 18 and 23 weeks would be predictive of spontaneous preterm birth (sPTB) at <35 weeks among asymptomatic high-risk women as defined by those with prior sPTB > 20 weeks. A prospective observational study of asymptomatic women with singleton gestations between 18 and 23weeks and one or more prior SPTB was performed. Women at their anatomy scan who opted into universal CL screening were enrolled. At enrollment, a vaginal speculum exam was performed to collect cervico-vaginal fluid from the posterior fornix using fetal fibronectin (FFN) swab. These women were then followed until delivery. Women with multiple gestations, rupture of membranes, vaginal bleeding, intercourse, or vaginal exam within 48 h of enrollment were excluded. Physicians were blinded to the qFFN levels, but the CL measurements were made available. The primary outcome was sPTB < 35 weeks. Of the 105 asymptomatic women with prior sPTB who were prospectively enrolled, 19 (18.1%) had recurrent sPTB < 37 weeks. None of the sPTB were iatrogenic. Using receiver-operating characteristic curves, qFFN ≥ 10 ng/mL had the highest sensitivity with subsequent lowest false negative rate, while FFN ≥ 50 ng/mL was identified as being the best balance of sensitivity and false positive rate for predicting sPTB < 35 weeks. As compared with CL ≤ 25 mm alone, with the use of CL ≤ 25 mm or qFFN ≥ 50 ng/mL as screening criteria for prediction of SPTB < 35 weeks, sensitivity improved from 18.2 to 63.6%, specificity decreased from 96.8 to 82.1%, positive predictive value (PPV) decreased from 40.0 to 29.2%, negative predictive value (NPV) marginally improved from 91.1 to 95.1%. In women with singleton gestations with prior SPTB, qFFN can be used as an adjunct to triage patients who are found to have a shortened cervix. Sensitivity and NPVs improved with the addition of qFFN to TVU CL screening alone in women with singleton gestations with prior SPTB. However, specificity and PPVs decreased.
为了确定在 18 至 23 周之间定量胎儿纤维连接蛋白（qFFN）联合经阴道超声（TVU）宫颈长度（CL）测量是否可以预测无症状高危女性（定义为既往 20 周以上自发性早产史）的 <35 周自发性早产（sPTB）。对 18 至 23 周有一个或多个既往 sPTB 的单胎妊娠的无症状女性进行了前瞻性观察性研究。在进行解剖扫描时，选择同意进行常规 CL 筛查的女性入组。在入组时，使用 FFN 拭子从前阴道穹隆采集宫颈阴道液进行阴道窥镜检查。然后对这些女性进行随访直至分娩。排除多胎妊娠、胎膜早破、阴道出血、性交或入组后 48 小时内阴道检查的女性。医生对 qFFN 水平不知情，但可获得 CL 测量值。主要结局为 <35 周的 sPTB。在 105 名有前瞻性既往 sPTB 的无症状女性中，19 名（18.1%）发生了复发性 <37 周 sPTB。无一例 sPTB 是医源性的。使用受试者工作特征曲线，qFFN≥10ng/mL 具有最高的敏感性，随后假阴性率最低，而 qFFN≥50ng/mL 被确定为预测 <35 周 sPTB 的敏感性和假阳性率最佳平衡。与单独使用 CL≤25mm 相比，使用 CL≤25mm 或 qFFN≥50ng/mL 作为预测 <35 周 sPTB 的筛查标准，敏感性从 18.2%提高到 63.6%，特异性从 96.8%降低到 82.1%，阳性预测值（PPV）从 40.0%降低到 29.2%，阴性预测值（NPV）略有提高从 91.1%到 95.1%。在有既往 sPTB 的单胎妊娠女性中，qFFN 可用于辅助分诊发现宫颈缩短的患者。在有既往 sPTB 的单胎妊娠女性中，qFFN 联合 TVU CL 筛查可提高敏感性和 NPV，但特异性和 PPV 降低。
