Effect of intravenous immunoglobulin (IVIG) in pregnant women with refractory obstetric antiphospholipid syndrome: A prospective single-arm interventional study
Not Applicable
- Conditions
- antiphospholipid syndrome
- Registration Number
- JPRN-UMIN000013496
- Lead Sponsor
- ational Center for Child Health and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 8
Inclusion Criteria
Not provided
Exclusion Criteria
1 History of drug hypersensitivity 2 History of heparin-induced thrombocytopenia 3 Hereditary fructose intolerance 4 IgA deficiency 5 Uterine anomalies, uterine submucosal myomas, or intrauterine tumors more than 10 cm in diameter 6 Inability to obtain written informed consent 7 Abnormal laboratory blood test results: Platelets are less than 50000/mm3 ALT, ALT, LDH, and ganma-GTP are more than 1.5 times the upper limit at each institution Plasma creatinine is more than 0.8 mg/dl
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ive birth rate after 30 weeks of gestation
- Secondary Outcome Measures
Name Time Method 1 Comparison of pregnancy outcomes (including birth outcomes) between previous pregnancies and the current pregnancy with the intervention (efficacy) 2 Assessment of the prevalence of pregnancy complications (gestational hypertension, preeclampsia, HELLP syndrome, placental abruption, and fetal growth restriction [FGR]) (efficacy) 3 Changes in antiphospholipid antibody titers (aCL IgG/IgM, aCL&beta2GP-I IgG, LA) (efficacy) 4 All adverse events, including laboratory test results during pregnancy and the postpartum period (safety)