2024-519853-12-00招募中3 期
Statin Intervention for Severe Early-Onset Placental Insufficiency: A Randomized Controlled Trial Assessing daily Administration as a Treatment Strategy (STATIN-PRE trial)
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau4 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2025年6月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 154
- 试验地点
- 4
- 主要终点
- Days of prolongation of pregnancy between inclusion and delivery; continuous (days).
研究概览
简要总结
To assess that daily 40 mgr of oral administration of pravastatin in pregnant individuals with PE and/or IUGR between 24.0 and 29.6 weeks of gestation will prolong duration of pregnancy compared to conventional management.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton fetus.
- •Between 24+0 to 29+6 weeks of gestation at the inclusion
- •Early-onset severe PE: women with a diagnosis of severe-preterm PE who are candidates for expectant management and have no clinical indication for immediate delivery, based on the clinical assessments of the attending doctors.
- •And/or IUGR: Diagnosis of early onset IUGR according to the SMFM classification with umbilical artery Doppler with absent/reversed diastolic flow; or estimated fetal weight <10th percentile plus pulsatility index (PI) of umbilical artery Doppler >95th percentil.
- •Able to give informed consent.
排除标准
- •Established maternal or fetal compromise that necessitated immediate delivery
- •Abnormal karyotype, structural abnormalities, or congenital infections.
- •Treatment with pravastatin or other statins prior to inclusion.
- •Active liver disease, including persistent and unexplained elevations of serum transaminases (3 times above the upper limit).
结局指标
主要结局
Days of prolongation of pregnancy between inclusion and delivery; continuous (days).
Days of prolongation of pregnancy between inclusion and delivery; continuous (days).
次要结局
未报告次要终点
研究者
Alejandra Espinosa
Scientific
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
研究点 (4)
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