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Peer-reviewedCC BY 4.0Frontiers in Medicine

Non-criteria antiphospholipid antibodies and pregnancy outcomes in recurrent pregnancy loss patients

  • Xiaoling Zhou1
  • Erdan Luo2
  • Xiaohui Cai3
  • Wei Chen4
  • Li Xiao5
  • Congrong Zhou4
  • Tao Wang6
  • Min Xiong6
  • Fan Lai6
  • Yi Deng1
6 affiliations
  1. 1Department of Pharmacy, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
  2. 2Department of Good Clinical Practice, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
  3. 3Department of Obstetrics and Gynecology, The Affiliated Hospital of Southwest Medical University, Luzhou, China
  4. 4Department of Traditional Chinese Medicine, Chengdu Women’s and Children’s Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
  5. 5Department of Medical Affairs, Chengdu Women’s and Children’s Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
  6. 6Department of Obstetrics, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
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Abstract

Objective: This study seeks to examine the prevalence of non-criteria antiphospholipid antibodies (NC-aPLs) in patients experiencing recurrent pregnancy loss (RPL) and to assess their potential association with pregnancy outcomes.

Methods: In this study,247 patients who had experienced at least two pregnancy losses and had been screened for 14 NC-aPLs were recruited between February 2021 and March 2024. Serum levels of NC-aPLs were assessed using line immunoassay (LIA), with the exception of anti-phosphatidylserine/prothrombin IgM (aPS/PT), which was quantified via enzyme-linked immunosorbent assay (ELISA). Pregnancy outcomes were subsequently compared between patients testing positive and negative for NC-aPLs, following the exclusion of individuals with positivity for criteria antiphospholipid antibodies (aPLs), chromosomal abnormalities, uterine anomalies, or thyroid dysfunction. Binary logistic regression analysis was employed to identify factors associated with adverse pregnancy outcomes (APO).

Results: The overall positivity rate for NC-aPLs was 38.46% (95 out of 247 participants), with anti-phosphatidylethanolamine (aPE) IgM being the most prevalent subtype, observed in 14.17% of cases. Patients who tested positive for NC-aPLs received more intensive therapeutic interventions, including low molecular weight heparin (LMWH), glucocorticoids, and hydroxychloroquine (HCQ). However, the incidence of APO did not significantly differ between NC-aPLs-positive and NC-aPLs-negative groups (53.68% vs. 46.71%, OR = 1.322, 95% CI 0.791–2.211, p = 0.286). Subgroup analyses did not reveal any significant associations between specific NC-aPLs subtypes [aPE IgM, anti-prothrombin (aPT) IgM, anti-annexin A5 (aAnxA5] IgM) and APO, nor between single and multiple NC-aPLs positivity. Binary logistic regression showed that medicinal degree was associated with lower odds of APO (1–2 drugs: aOR=0.177, 95% CI 0.055–0.569, P = 0.004; 3–4 drugs: aOR = 0.102, 95% CI 0.037–0.283, P < 0.001), while neither single positivity (aOR = 1.553, 95% CI 0.799–3.017, P = 0.194) nor multiple positivity for NC-aPLs (aOR = 1.942, 95% CI 0.798–4.726, P = 0.144) was significantly associated with APO.

Conclusion: NC-aPLs are detectable in a substantial proportion of patients with RPL. However, this study did not identify any association between NC-aPLs and APO. Patients who tested positive for NC-aPLs received significantly more intensive pharmacological treatment, which was associated with lower odds of APO. This confounding factor may obscure the potential effects of NC-aPLs. Additionally, the limited sample size and the use of a single-time LIA for NC-aPLs detection may introduce bias into the current findings. Further research involving large-scale cohorts and repeated standardized antibody testing is necessary to elucidate the clinical relevance of NC-aPLs and APO.

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Cite

BibTeXRIS
BibTeX
@article{zhou2026noncriteria,
  title = {{Non-criteria antiphospholipid antibodies and pregnancy outcomes in recurrent pregnancy loss patients}},
  author = {Xiaoling Zhou and Erdan Luo and Xiaohui Cai and Wei Chen and Li Xiao and Congrong Zhou and Tao Wang and Min Xiong and Fan Lai and Yi Deng},
  journal = {Frontiers in Medicine},
  year = {2026},
  month = oct,
  doi = {10.3389/fmed.2026.1961459},
  url = {https://doi.org/10.3389/fmed.2026.1961459},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Non-criteria antiphospholipid antibodies and pregnancy outcomes in recurrent pregnancy loss patients
AU  - Xiaoling Zhou
AU  - Erdan Luo
AU  - Xiaohui Cai
AU  - Wei Chen
AU  - Li Xiao
AU  - Congrong Zhou
AU  - Tao Wang
AU  - Min Xiong
AU  - Fan Lai
AU  - Yi Deng
PY  - 2026
DA  - 2026/10/21
JO  - Frontiers in Medicine
DO  - 10.3389/fmed.2026.1961459
UR  - https://doi.org/10.3389/fmed.2026.1961459
AB  - Objective: This study seeks to examine the prevalence of non-criteria antiphospholipid antibodies (NC-aPLs) in patients experiencing recurrent pregnancy loss (RPL) and to assess their potential association with pregnancy outcomes.  Methods: In this study,247 patients who had experienced at least two pregnancy losses and had been screened for 14 NC-aPLs were recruited between February 2021 and March 2024. Serum levels of NC-aPLs were assessed using line immunoassay (LIA), with the exception of anti-phosphatidylserine/prothrombin IgM (aPS/PT), which was quantified via enzyme-linked immunosorbent assay (ELISA). Pregnancy outcomes were subsequently compared between patients testing positive and negative for NC-aPLs, following the exclusion of individuals with positivity for criteria antiphospholipid antibodies (aPLs), chromosomal abnormalities, uterine anomalies, or thyroid dysfunction. Binary logistic regression analysis was employed to identify factors associated with adverse pregnancy outcomes (APO).  Results: The overall positivity rate for NC-aPLs was 38.46% (95 out of 247 participants), with anti-phosphatidylethanolamine (aPE) IgM being the most prevalent subtype, observed in 14.17% of cases. Patients who tested positive for NC-aPLs received more intensive therapeutic interventions, including low molecular weight heparin (LMWH), glucocorticoids, and hydroxychloroquine (HCQ). However, the incidence of APO did not significantly differ between NC-aPLs-positive and NC-aPLs-negative groups (53.68% vs. 46.71%, OR = 1.322, 95% CI 0.791–2.211, p = 0.286). Subgroup analyses did not reveal any significant associations between specific NC-aPLs subtypes [aPE IgM, anti-prothrombin (aPT) IgM, anti-annexin A5 (aAnxA5] IgM) and APO, nor between single and multiple NC-aPLs positivity. Binary logistic regression showed that medicinal degree was associated with lower odds of APO (1–2 drugs: aOR=0.177, 95% CI 0.055–0.569, P = 0.004; 3–4 drugs: aOR = 0.102, 95% CI 0.037–0.283, P < 0.001), while neither single positivity (aOR = 1.553, 95% CI 0.799–3.017, P = 0.194) nor multiple positivity for NC-aPLs (aOR = 1.942, 95% CI 0.798–4.726, P = 0.144) was significantly associated with APO.  Conclusion: NC-aPLs are detectable in a substantial proportion of patients with RPL. However, this study did not identify any association between NC-aPLs and APO. Patients who tested positive for NC-aPLs received significantly more intensive pharmacological treatment, which was associated with lower odds of APO. This confounding factor may obscure the potential effects of NC-aPLs. Additionally, the limited sample size and the use of a single-time LIA for NC-aPLs detection may introduce bias into the current findings. Further research involving large-scale cohorts and repeated standardized antibody testing is necessary to elucidate the clinical relevance of NC-aPLs and APO.
SN  - 2296-858X
ER  -