EUCTR2020-000315-76-PT进行中（未招募）1 期
ow molecular weight heparin in the treatment of early fetal growth restriction - HepaGrowth
Centro Hospitalar Universitário de Lisboa Central, EPE0 个研究点目标入组 120 人开始时间: 2021年10月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Eligible women referred to our FGR unit who consent to participate in the study. Eligible women are considered those who fulfill all the following eligibility criteria: a) being over 18 years old; b) being able to provide consent; c) having a viable singleton pregnancy with diagnosed early FGR confirmed in our unit according to the 2016 consensus criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •diagnosed fetal chromosomal abnormalities; c) associated fetal morphological malformations; d) evidence of fetal infection (serological or after invasive testing); e) use of aspirin, LMWH or NFH in the index pregnancy before randomization; f) maternal history of allergy to LMWH or non-fractionated heparin (NFH); g) hypersensitivity to pork products; h) maternal history of heparin-induced thrombocytopenia; i) maternal thrombocytopenia (platelets < 100 000); k) history of maternal anticoagulant hemostatic disorder; j) presence of placental hematoma; k) maternal diabetic retinopathy; l) bacterial endocarditis; m) high risk of bleeding (recent ophthalmological, spinal or brain surgery); n) previous hemorrhagic stroke; o) persistent blood pressure > 160/100 mmHg, despite optimal anti-hypertensive regimen; p) active ulcerative or angiodysplastic diseases; q) history of severe renal disease (eGFR <30mL/min).
研究者
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