anti-phospholipid antibody syndrome
Conditions
Interventions
Intravenous immunoglobulin administration (IVIG) during early pregnancy, in addition to standard anticoagulation therapy.
A five-day course of IVIG (400 mg/kg body weight) was initiated soon after co
Sponsors
Murashima Atsuko
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Pregnant women with APS diagnosed according to the international criteria who meet the following inclusion criteria will be enrolled: 1.One or more unexplained episodes of fetal death of a morphologically normal fetus at or beyond the 10th week of gestation, an episode of fetal death without fetal chromosomal abnormalities at or beyond the 10th week of gestation, or an episode of preterm delivery before the 30th week of gestation due to pregnancy complications (e.g., severe preeclampsia or gestational hypertension, FGR, or placental abruption) despite standard anticoagulation therapy. 2.A history of vascular thrombosis due to pregnancy despite standard anticoagulation therapy.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate after 30 weeks of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Contacts
Public ContactKayoko Kaneko
National Center for Child Health and Development
Outcome results
None listed