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A randomized controlled trial of hydroxychloroquine in the treatment of recurrent spontaneous abortion resulted from ''atypical antiphospholipid syndrome with positive anticardiolipin antibodies''

A randomized controlled trial of hydroxychloroquine in the treatment of recurrent spontaneous abortion resulted from ''atypical antiphospholipid syndrome with positive anticardiolipin antibodies''

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035947
Enrollment
Unknown
Registered
2020-08-20
Start date
2020-09-30
Completion date
Unknown
Last updated
2020-08-24

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

Conditions

Recurrent spontaneous abortion due to atypical antiphospholipid antibody positive syndrome

Interventions

Control group:Daphone: 10mg, Q8h, oral
Hydroxychloroquine group 1: hydroxychloroquine 200mg/ day + Dafotone orally
Hydroxychloroquine group 2:hydroxychloroquine 200mg/ day + Daphne + aspirin (50mg/ day) orally

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1) Married women aged 20 to 35 years; 2) Meet ACA positive atypical APS diagnostic criteria.

Exclusion criteria

Exclusion criteria: 1) Progesterone <20ng/ml; 2) Positive anti-lupus anticoagulant (LA); 3) Those who do not meet the diagnostic criteria for this disease; 4) Patients with reproductive system tumors and malformations; 5) Patients with severe diseases such as heart, brain, liver and kidney and abnormal mental state; 6) Chromosomal abnormalities and blood type incompatibility between the husband and wife; 7) Abnormal endocrine function; 8) The eugenics and eugenics test suggested cytomegalovirus, Toxoplasma virus, rubella virus and herpes simplex virus infection; 9) Abnormal blocking antibody; 10) Abnormal semen of the husband; 11) Those who have recently used similar drugs for treatment, or taken drugs with related or antagonistic effects, resulting in the difficulty in determining the efficacy of drugs.

Design outcomes

Primary

MeasureTime frame
ACA and related antibodies;Indicators of coagulation function;Pregnancy-related hormone indicators;Fetal growth and development related indicators;

Countries

China

Contacts

Public ContactYinyan He

Shanghai General Hospital

amelie0228@126.com+86 18939761117

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026