A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Number of Newborns With a Birth Platelet Count > 50,000/uL
研究概览
简要总结
The purposes of this study are to provide medical management by giving treatment to the mother that will bring up the fetal platelet count and to minimize the number of invasive procedures to the fetus (which may result in serious fetal injuries).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
participants and their physicians will know if they are receiving IVIG x 2 or IVIG x1 plus prednisone
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women are eligible for inclusion into the Very High Risk Group if they:
- •are PLA-1 (platelet antigen A1) negative and have known platelet incompatibility with their fetus
- •have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation (as best as could be estimated)
- •are less than 19 weeks gestation
- •Pregnant women are eligible for inclusion into the High Risk Group if they:
- •are PLA-1 negative and have known platelet incompatibility with the fetus
- •have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation (as best as could be estimated)
- •are between 12-30 weeks gestation
- •Pregnant women are eligible for inclusion into the Standard Risk Group if they:
- •are PLA-1 negative and have known platelet incompatibility with the fetus
- •have not had a previous child who suffered an antenatal hemorrhage
- •are between 20-30 weeks gestation
排除标准
- •Women are not eligible for inclusion into the Very High Risk Group if they:
- •have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation
- •are greater than 19 weeks gestation
- •Women are not eligible for inclusion into the High Risk Group if they:
- •have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation
- •are greater than 30 weeks gestation
- •Women are not eligible for inclusion into the Standard Risk Group if they:
- •have had a previous child who suffered an antenatal hemorrhage
- •are greater than 30 weeks gestation
研究组 & 干预措施
IVIG x 2
IVIG 2 g/kg/wk divided into 2 infusions per week for women with a fetus affected by FNAIT
干预措施: IVIG (Intravenous Immunoglobulin) (Drug)
IVIG x 1 + prednisone
IVIG 1 g/kg/wk in 1 infusion per week + prednisone 0.5 mg po daily for women with a fetus affected by FNAIT
干预措施: IVIG (Intravenous Immunoglobulin) (Drug)
IVIG x 1 + prednisone
IVIG 1 g/kg/wk in 1 infusion per week + prednisone 0.5 mg po daily for women with a fetus affected by FNAIT
干预措施: prednisone (Drug)
结局指标
主要结局
Number of Newborns With a Birth Platelet Count > 50,000/uL
时间窗: 32-40 weeks (the endpoint is the birth which is not at the same number of weeks for all of the babies. This is why the weeks are not listed specifically eg week 40
this uses the birth platelet count of the fetuses from the study when they are born
次要结局
- Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study(time of ICH (range 20-40 wks))
- Number of Fetal Platelet Counts > 50,000/uL(32 +/- 2 weeks)