JPRN-jRCTs031180116已完成未知
Effect of intravenous immunoglobulin (IVIG) in pregnant women with refractory obstetric antiphospholipid syndrome: A prospective single-arm interventional study - OAPS-IVIG study
Murashima Atsuko0 个研究点目标入组 8 人开始时间: 2019年2月12日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
The IVIG intervention was highly effective compared to the historical control, with a live birth rate of 50% after 30 weeks gestation. However, only 2 patients were able to achieve a live birth with the addition of IVIG alone, and in other cases, rituximab or statins were added after IVIG administration because IVIG monotherapy was considered to be less effective for these cases.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 <= 50age old（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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
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