NCT03324139已完成3 期
Treatment of Intrauterine Growth Restriction With Low Molecular Heparin: Randomized Clinical Trial. Tratamiento Del Crecimiento Intrauterino Restringido Precoz Con Heparina de Bajo Peso Molecular: Ensayo clínico Aleatorizado.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Efficacy of low molecular weight heparin in the prolongation of gestation.
研究概览
简要总结
TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN.
详细描述
TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN: RANDOMIZED CLINICAL TRIAL (TRACIP STUDY).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women older than 18 years.
- •Unique gestations
- •Diagnosis of early placental intrauterine growth (according to Delphi classification): <32 weeks at diagnosis + Doppler AU with absent / reverse flow or (estimated fetal weight <10 percentile + pulsed Doppler ultrasonography) or (estimated fetal weight <percentile 10 + pulsed uterine artery Doppler).
- •Patient giving written informed consent to participate in the study.
排除标准
- •Chromosopathies, genetic alterations or fetal malformations.
- •Diagnostic treatment with low molecular weight heparins, oral anticoagulants or acetylsalicylic acid prior to inclusion.
- •History of heparin-induced thrombocytopenia.
- •Active hemorrhage or increased risk of bleeding due to changes in hemostasis.
- •Severe hepatic or pancreatic function disorder.
- •Organic lesions that may bleed (eg, active peptic ulcer, hemorrhagic stroke, aneurysms, or brain tumors).
研究组 & 干预措施
Study Group
Experimental
Treatment with low molecular weight Heparin.
干预措施: Low molecular weight heparin (Drug)
Control Group
Placebo Comparator
Treatment with Placebo.
干预措施: Placebos (Drug)
结局指标
主要结局
Efficacy of low molecular weight heparin in the prolongation of gestation.
时间窗: 13 weeks maximum
Measured as gestational age (weeks) at birth (dated by ultrasonography \<14 weeks by measurement of caudal skull length).
次要结局
- Efficacy of low molecular weight heparin in reducing thrombotic and ischemic placental lesions(13 weeks maximum)
- Efficacy of low molecular weight heparin in reducing neonatal morbidity(13 weeks maximum)
- Demonstrate that low molecular weight heparin improves the pro-angiogenic and anti-inflammatory profile.(13 weeks maximum)
研究者
研究点 (1)
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