recurrent spontaneous abortion
Conditions
Interventions
Prednisone group:Prednisone 10mg daily (2 tablets of 5mg each) until 10 weeks of gestation
Control group:placebo 20mg daily (2 tablets of 10mg each) until 10 weeks of gestation
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the RSA diagnostic criteria (ESHRE diagnostic Criteria 2018): =2 clinical pregnancy losses before 24 weeks, excluding biochemical pregnancies and pregnancies with an undefined site; (2) The woman is aged 20-45; (3) Completed comprehensive RSA etiology screening before pregnancy, with no other clear causes of miscarriage, diagnosed as URSA; (4) Body mass index (BMI) at screening was between 19 and 25 kg/m2; (5) Pregnancy achieved through natural intercourse or assisted reproductive technology (including IVF-ET or artificial insemination). Blood ß-hCG levels were measured at =25IU/L at 14 days after coitus or artificial insemination, or at 10-14 days after confirmed embryo transfer. (6) Peripheral blood pNK level was measured within 2 months before conception and retested at 4 weeks of gestation, with levels higher than before gestation; (7) No history of prednisone and vitamin B6 allergy or contraindications to drug use; (8) Understanding the purpose and implementation process of this study, voluntarily participating, willing to follow medical advice for treatment, and capable of long-term follow-up; (9) Patients and their families agree to participate in the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Combined with other known and specific causes of miscarriage: chromosomal abnormalities in both partners; Anatomical factors (including congenital anatomical abnormalities: septate uterus, bicornuate uterus, arcuate uterus, unicornuate uterus, didelphic uterus, uterine malformations, and congenital cervical insufficiency, as well as acquired anatomical abnormalities: Asherman's syndrome, cervical insufficiency, uterine fibroids, etc.); Endocrine factors: polycystic ovary syndrome, luteal phase insufficiency, hyperprolactinemia, hyperandrogenemia, thyroid dysfunction; Hyperglycemia, insulin resistance; Immunological factors (including but not limited to autoimmune diseases: antiphospholipid syndrome, systemic lupus erythematosus, undifferentiated connective tissue disease, Sjögren's syndrome, rheumatoid arthritis, and systemic sclerosis); Thrombophilia (PC, PS deficiency, antiphospholipid syndrome, and hyperhomocysteinemia, etc.); Infectious factors (untreated endometritis). (2) Good health condition, no acute or chronic diseases, and other contraindications to pregnancy: concurrent severe medical and surgical conditions, such as cardiovascular diseases (uncontrolled severe hypertension, blood pressure >160/110 mmHg), liver disease (transaminases >2xULN), blood system diseases (platelet count 1.5xULN), infectious diseases, and other surgical diseases; (3) Use of immunotherapy in the last 3 months; (4) Allergic to prednisone, vitamin B6, and other investigational drugs; (5) Subjects who participated in other clinical trials 90 days prior to randomization or concurrently; (6) The researcher has determined that the patient's condition is not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate;Miscarriage rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy complications ;Neonatal outcomes; | — |
Countries
China
Contacts
Public ContactQiong Wang
Reproductive Medicine Center, The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed