Department of Reproductive Medicine, Lanzhou University Second Hospital, No. 82 Cuiyingmen, Chengguan District, Lanzhou, 730030, China.
Reprod Sci. 2024 Mar;31(3):746-753. doi: 10.1007/s43032-023-01388-5. Epub 2023 Nov 6.
The aim of this study was to investigate the subsequent early pregnancy outcomes in women positive for non-criteria antiphospholipid antibodies (NC-aPLs) before pregnancy. A total of 273 patients who had experienced sporadic or recurrent pregnancy loss and had been screened for 13 NC-aPLs at preconception were recruited in this study from September 2019 to February 2022. Serum levels of NC-aPLs were measured by ELISA using specific kits. The primary outcome was early pregnancy loss, and the secondary outcomes were biochemical pregnancy, clinically confirmed pregnancy loss, and ongoing pregnancy. Among these subjects, 56 patients had one previous pregnancy loss, and 217 had recurrent pregnancy loss (RPL). The NC-aPLs (+) and NC-aPLs (-) groups had similar rates of early pregnancy loss (EPL) after adjustment, regardless of the number of positive NC-aPLs (aOR = 1.054, 95% CI 0.602-1.846). Other outcomes were comparable in both groups, including the rates of biochemical pregnancy (aOR = 1.344, 95% CI 0.427-4.236), clinically confirmed pregnancy loss (aOR = 0.744, 95% CI 0.236-2.344), and ongoing pregnancy (aOR = 0.949, 95% CI 0.542-1.660). Based on sensitivity analysis, the NC-aPLs (+) were not associated with adverse early pregnancy outcomes in women with RPL. Furthermore, the difference in gestational weeks of pregnancy loss between the two groups was also insignificant. This study found no evidence linking preconception NC-aPL positivity to early pregnancy outcomes but offers a reference for future research to clarify NC-aPLs' potential clinical impact.
本研究旨在探讨孕前非标准抗磷脂抗体(NC-aPL)阳性妇女的早期妊娠结局。本研究于 2019 年 9 月至 2022 年 2 月,共招募了 273 例曾经历过偶发性或复发性妊娠丢失且在孕前筛查了 13 种 NC-aPL 的患者。采用 ELISA 法,用专用试剂盒检测 NC-aPL 水平。主要结局是早期妊娠丢失,次要结局是生化妊娠、临床确诊妊娠丢失和持续妊娠。在这些患者中,56 例有一次既往妊娠丢失,217 例有复发性妊娠丢失(RPL)。调整后,无论 NC-aPL 阳性数量如何,NC-aPL(+)和 NC-aPL(-)组的早期妊娠丢失(EPL)发生率相似(aOR=1.054,95%CI 0.602-1.846)。两组其他结局相似,包括生化妊娠率(aOR=1.344,95%CI 0.427-4.236)、临床确诊妊娠丢失率(aOR=0.744,95%CI 0.236-2.344)和持续妊娠率(aOR=0.949,95%CI 0.542-1.660)。基于敏感性分析,RPL 患者的 NC-aPL 阳性与不良早期妊娠结局无关。此外,两组妊娠丢失的孕周差异也无统计学意义。本研究未发现孕前 NC-aPL 阳性与早期妊娠结局有关,但为未来研究阐明 NC-aPLs 的潜在临床影响提供了参考。