Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Fetal loss
研究概览
简要总结
This study will address the value of adding intralipid infusion in reducing pregnancy complications related to antiphospholipid syndrome
详细描述
This study will be conducted in the Department of Obstetrics and Gynecology, Tanta University on patients attending the antenatal care clinic and also on patients attending the researchers private clinics for antenatal care. The number of patients enrolled in the study will be 105 patients after application of inclusion and exclusion criteria.
All women wil be thoroughly informed about the study aims and through discussion about the procedure, associated benefits and risks and will sign a written consent.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women at booking date who were already diagnosed to have antiphospholipid syndrome (APS) .
排除标准
- •Patients with gestational age ≥ 9 weeks
- •patients with diagnosed other auto-immune disorder
- •patients with chronic hypertension, diabetes mellitus, thyroid disorders,
- •patient with renal diseases
- •patients who requested to withdraw from the study at any point .
研究组 & 干预措施
Intralipid group
the patients will receive the conventional basic treatment of APS (Dual low dose aspirin (LDA) (Ezacard 75mg) once daily and Low molecular weight heparin (LMWH) (clexane 4000 IU) injection once daily. In addition intralipid 20% (Frezenius, Clayton, NC, USA) in a dose of 4 ml diluted in 250 ml 0.9% regular saline to be infused IV and to be repeated every 2 weeks all over the pregnancy.
干预措施: Intralipid, 20% Intravenous Emulsion (Drug)
Standard care group
the patients will receive the conventional basic treatment of APS (Dual low dose aspirin (LDA) (Ezacard 75mg) once daily and Low molecular weight heparin (LMWH) (clexane 4000 IU) injection once daily.
干预措施: Conventional therapy of antiphospholipis syndrome (Drug)
结局指标
主要结局
Fetal loss
时间窗: within 9 months
Fetal demise
Preeclampsia
时间窗: > 20 weeks
Hypertesion, proteiuria and or edema
Premature delivery
时间窗: Before 37 weeks
occurrence of preterm labour before 37 weeks
fetal growth restriction
时间窗: within 9 months
Fetal poderal index less than normal
次要结局
未报告次要终点
研究者
Ayman S Dawood, MD
Lecturer
Tanta University