recurrent spontaneous abortion
Conditions
Interventions
aspirin group :NA
Hydroxychloroquine group :NA
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. 2 or more miscarriages occurring before 24 weeks of pregnancy, without a history of full-term delivery 2. Women of childbearing age between 20 and 40 years old 3. Spouses have normal peripheral blood chromosome karyotypes and no family history of inheritance 4. Gynecological examination, B-ultrasound examination, hysteroscopy examination, and hysterosalpingography are performed to rule out anatomical abnormalities of the patient's reproductive organs 5. Normal endocrine function, including normal menstrual cycle, biphasic basal body temperature, normal ovarian ovulation monitored by B-ultrasound, and no history of diabetes, hyperthyroidism and other endocrine diseases 6. Exclude antiphospholipid antibody syndrome and other autoimmune diseases: plasma cardiolipin antibodies and ß -2 glycoprotein 1 antibodies (IgG and IgM) were tested negative twice with an interval of 12 week, and there was no history of thrombosis, intrauterine growth restriction, or preeclampsia 7. Normal plasma cysteine levels and normal coagulation function 8. Good compliance, signed informed consent form before the experiment 9. ANA testing with an interval of 12 weeks and two positive ANA tests (titer of 1:80 or above) or above.
Exclusion criteria
Exclusion criteria: 1. RSA caused by precise reasons 2. APS and other autoimmune diseases 3. Chromosomal abnormalities in couples and embryos 4. Maternal endocrine disorders: luteal insufficiency, polycystic ovary syndrome, premature ovarian failure (FSH = 20miu/L during follicular phase), hyperprolactinemia, thyroid disease, diabetes, other hypothalamic, pituitary, and adrenal disorders 5. Abnormal maternal reproductive tract: uterine malformation, cervical incompetence, uterine fibroids larger than 5cm 6. Female reproductive tract infection 7. Hyperhomocysteinemia 8. Individuals with severe heart, liver, kidney and other important organ diseases, as well as blood and endocrine system disorders and a medical history (severity evaluation criteria: ALT or AST >= 2 times the upper limit of normal values; Patients with endogenous creatinine clearance rate<30 mL/min; White blood cell count<2.5 × 10^9/L; hemoglobin<85g/L; Platelet count<50 × 10^9/L) 9. History of thrombosis and mid to late pregnancy miscarriage 10. History of premature birth caused by severe eclampsia or preeclampsia or severe placental insufficiency 11. History of allergy to hydroxychloroquine or aspirin enteric coated tablets 12. Individuals with a history of digestive ulcers or gastric bleeding in the past 13. Individuals with a history of malignant tumors 14. Patients with mental illness 15. Individuals with epilepsy and other neurological disorders 16. Possible contraindications for hydroxychloroquine, such as concomitant macular degeneration or visual field defects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| live birth rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy complicated hypertension ;Premature birth (delivery between 28 and 37 weeks of gestation) ;Miscarriage (Termination of pregnancy within 28 weeks) ;Postpartum bleeding (vaginal bleeding exceeding 500ml within 24 hours after delivery of the fetus) ;Birth defects (congenital fetal heart block, fetal malformation, etc.) ;Intrauterine growth retardation (fetal birth weight below the 10th percentile or two standard deviations of the average gestational age) ; | — |
Countries
China
Contacts
Public ContactLi Li
Peking University Third Hospital
Outcome results
None listed