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Establishment and follow-up study of a cohort of abnormal pregnancies with autoantibodies

Establishment and follow-up study of a cohort of abnormal pregnancies with autoantibodies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129310
Enrollment
Unknown
Registered
2026-08-03
Start date
2025-08-01
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal autoantibodies

Interventions

Observation group:None

Sponsors

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant women aged 18 to 45 years old; 2. Those with abnormal autoantibodies detected before (or during) pregnancy, including antinuclear antibodies, anticardiolipin antibodies, antineutrophil cytoplasmic antibodies, etc.; 3. Singleton pregnancy; 4. The establishment of the "Maternal Health Handbook" no later than 16 weeks of pregnancy, and having complete prenatal examination records; 5. Agree to participate in this study and sign the informed consent form, and have the conditions for follow-up until the end of pregnancy and 42 days postpartum.

Exclusion criteria

Exclusion criteria: 1. Any chromosomal abnormality in either partner; 2. This pregnancy structure indicates chromosomal abnormalities in the fetus; 3. Abnormalities in the female reproductive system anatomy (such as unilateral/double-lobed uterus, septate uterus malformation, etc.); 4. The female has untreated obstetric and gynecological diseases that may affect the pregnancy outcome, such as intrauterine adhesions, endometrial polyps, uterine adenomyosis, endometriosis, uterine tumors, etc. 5. Exclude patients with thrombocytopenia, hemolytic anemia, heart valve disease, kidney disease and skin ulcer symptoms caused by other reasons, such as drugs, infections, blood system diseases, genetic metabolic diseases, etc. 6. Exclude patients with severe cardiovascular diseases, damage to important organs such as the kidneys and liver, severe blood and endocrine system disorders (such as liver cirrhosis, aplastic anemia, thyroid storm, etc.); 7. Patients with a history of active malignant tumors (within 5 years) and those undergoing radiotherapy and chemotherapy; 8. Patients who have received organ or bone marrow transplantation in the past year; 9. Patients with mental disorders; 10. Incomplete clinical data; 11. Patients considered not suitable to participate in this clinical study by the researchers.

Design outcomes

Primary

MeasureTime frame
Pregnancy outcome;The condition of a newborn at birth;

Secondary

MeasureTime frame
The effects of other potential risk factors on the outcome of pregnancy;The correlation between different types of autoantibodies and pregnancy outcomes;The impact of different antithrombotic treatment regimens on pregnancy outcomes;The association between changes in immune-inflammatory indicators during pregnancy and abnormal autoantibodies as well as pregnancy outcomes;

Countries

China

Contacts

Public ContactLi Liu

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

20328@renji.com+86 21 68385609

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026