The Safety and Outcome of Intra-amniotic DIGOXIN Injection for Feticide Prior to Second Trimester Abortion
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Efficiency of intra-amniotic Digoxin injection for second trimester feticide
研究概览
简要总结
In second trimester abortion above 22 weeks the investigators usually inject intra-cardiac Kcl for feticide. Digoxin intra-amniotic injection has been described in the literature in doses of 1-1.5 mg. with a success rate of about 80%, and up to 24 weeks. Our aim in this study is to investigate the safety and success rate of 1.5-2 mg. digoxin, intra-amniotic up to 30 weeks pregnancy .
详细描述
- The digoxin will be injected intra-amniotic with U.S guided, trying to avoid any placental passage or intravascular injection /
- Any patient will have prior to the procedure a full examination including E.C.G and cardiac clearance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy women with no medical, cardiac, hypertension, liver or renal problems - pregnant in their 20-30 week gestation,
- •that need to have abortion due to fetal anomalies or any other reason
- •need to have feticide prior to the procedure
排除标准
- •any patient with medical problem that may be a contra-indication to Digoxin
- •cardiac problems,
- •prior cardiac surgery,
- •liver or kidney disease,
- •hyper tension etc.
研究组 & 干预措施
second trimester abortion , feticide
all patients admitting to second trimester abortion above 22 weeks will be injected intra-amniotic DIGOXIN for feticide .
干预措施: Intra-amniotic injection of DIGOXIN (Drug)
结局指标
主要结局
Efficiency of intra-amniotic Digoxin injection for second trimester feticide
时间窗: a year
To measure the Success rate of intra-amniotic Digoxin injection for feticide prior to second trimester abortion
次要结局
未报告次要终点