Cao Yurong, Li Weiwei, Ma Linna
Department of Obstetrics and Gynecology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Department of Reproductive Medicine, the First Affiliated Hospital of Hainan Medical College, Hainan, China.
PLoS One. 2025 Jun 24;20(6):e0326384. doi: 10.1371/journal.pone.0326384. eCollection 2025.
Threatened abortion is a common obstetric complication where early risk stratification is crucial for clinical management. CA125, a glycoprotein biomarker produced by endometrial and trophoblastic tissues, may serve as a valuable prognostic indicator as its elevated levels often reflect placental inflammation or detachment in this condition. To systematically assess its clinical value, we conducted a meta-analysis evaluating the prognostic accuracy of serum CA125 levels for miscarriage risk in patients with threatened abortion.
We systematically searched Web of Science, Medline via PubMed, ScienceDirect, EMBASE, Geenmedical, Cochrane Library, and Wiley databases from inception to May 30, 2024 for studies evaluating either CA125's prognostic value for miscarriage risk in threatened abortion, or serum markers' prognostic value for pregnancy outcomes. Two researchers independently screened literature and extracted data. Study quality and evidence certainty were assessed using QUAPAS and GRADE frameworks respectively. Meta-analyses were performed using Stata 17 and Review Manager 5.3.
A total of 13 studies involving 1166 patients with threatened abortion were included in this meta-analysis. The pooled estimates demonstrated that CA125 exhibited the following prognostic performance for predicting miscarriage risk in patients with threatened abortion: sensitivity, 89% (95% CI: 83-93%); specificity, 91% (95% CI: 84-95%); positive likelihood ratio (PLR), 10.2 (95% CI: 5.4-19.3); negative likelihood ratio (NLR), 0.13 (95% CI: 0.08-0.19); diagnostic odds ratio (DOR), 82 (95% CI: 31-212); and area under the summary receiver operating characteristic curve (SROC AUC), 0.95 (95% CI: 0.92-0.96). Elevated serum CA125 levels were significantly associated with an increased risk of miscarriage. According to the GRADE assessment, the certainty of evidence was moderate for sensitivity but low for other parameters, primarily due to heterogeneity, risk of bias, and other confounding factors.
Current evidence with moderate certainty indicates that serum CA125 demonstrates high prognostic value for assessing miscarriage risk in threatened abortion, particularly for identifying high-risk patients. However, due to low-certainty specificity findings, caution is warranted when using CA125 to rule out miscarriage. While these results support CA125's potential as a complementary tool to ultrasound, further studies are required to establish standardized cut-off values for clinical implementation.
先兆流产是一种常见的产科并发症，早期风险分层对临床管理至关重要。CA125是一种由子宫内膜和滋养层组织产生的糖蛋白生物标志物，其水平升高通常反映了这种情况下的胎盘炎症或剥离，可能是一种有价值的预后指标。为了系统评估其临床价值，我们进行了一项荟萃分析，评估血清CA125水平对先兆流产患者流产风险的预后准确性。
我们系统检索了Web of Science、通过PubMed检索的Medline、ScienceDirect、EMBASE、Geenmedical、Cochrane图书馆和Wiley数据库，检索时间从建库至2024年5月30日，以查找评估CA125对先兆流产流产风险的预后价值或血清标志物对妊娠结局的预后价值的研究。两名研究人员独立筛选文献并提取数据。分别使用QUAPAS和GRADE框架评估研究质量和证据确定性。使用Stata 17和Review Manager 5.3进行荟萃分析。
本荟萃分析共纳入13项研究，涉及1166例先兆流产患者。汇总估计表明，CA125在预测先兆流产患者流产风险方面表现出以下预后性能：敏感性为89%（95%CI：83 - 93%）；特异性为91%（95%CI：84 - 95%）；阳性似然比（PLR）为10.2（95%CI：5.4 - 19.3）；阴性似然比（NLR）为0.13（95%CI：0.08 - 0.19）；诊断比值比（DOR）为82（95%CI：31 - 212）；汇总受试者操作特征曲线下面积（SROC AUC）为0.95（95%CI：0.92 - 0.96）。血清CA125水平升高与流产风险增加显著相关。根据GRADE评估，证据确定性对于敏感性为中等，但对于其他参数为低，主要是由于异质性、偏倚风险和其他混杂因素。
目前具有中等确定性的证据表明，血清CA125在评估先兆流产流产风险方面具有较高的预后价值，特别是在识别高危患者方面。然而，由于特异性结果的确定性较低，在使用CA125排除流产时应谨慎。虽然这些结果支持CA125作为超声辅助工具的潜力，但需要进一步研究以建立临床应用的标准化临界值。
