2023-510382-10-00招募中3 期
Metformin for the prolongation of pregnancy in preterm preeclampsia: the PI-NL trial
Amsterdam UMC8 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年9月24日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- Gestational prolongation (in days)
研究概览
简要总结
To assess whether metformin, compared to placebo, prolongs gestation (for at least 5 more days) in pregnant individuals with preterm PE.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment phase
- 盲法
- Double (Subject, Investigator, Carer)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older
- •Singleton pregnancy
- •Gestational age between 23+0 and 31+6 weeks
- •Estimated fetal weight >400 grams
- •There is no clear indication (maternal or fetal) or intention, by both the treating multidisciplinary team and the patient after counseling, to immediately deliver (or directly after corticosteroid administration) or to terminate the pregnancy otherwise
- •A diagnosis of PE, according to PI-NL criteria
- •Ability to understand English or Dutch
- •Ability and willingness to provide written informed consent
排除标准
- •Aged <18 years
- •Multiple pregnancy
- •Current use of metformin or a clinical indication for the use of metformin
- •A decision for immediate delivery (including cases where corticosteroids are administered with planned delivery directly after completion of treatment) or termination of pregnancy (e.g., due to disease severity in the patient combined with a dismal prognosis for the fetus), as made by the treating multidisciplinary team and the parent(s)
- •Contraindication(s) for use of metformin
- •Use of drugs that might interact with metformin
- •Suspicion of a major fetal anomaly and/or chromosomal abnormality
- •Unable or unwilling to (completely) understand or provide informed consent, due to language, culture, or other barriers
结局指标
主要结局
Gestational prolongation (in days)
Gestational prolongation (in days)
次要结局
- Combined endpoint of maternal adverse outcome, consisting of maternal death (death during pregnancy or within 42 days of delivery), eclampsia, pulmonary edema, severe renal impairment, cerebrovascular accident, placental abruption, and/or liver hematoma or rupture.
- Combined endpoint of fetal adverse outcome, consisting of intrauterine fetal death (IUFD, including intrapartum death), suboptimal fetal condition based on the heart rate pattern on the CTG (as judged by the treating clinician), and/or fetal growth restriction (FGR)
- Combined endpoint of neonatal adverse outcome, consisting of neonatal death (within 28 days of birth), intraventricular hemorrhage (grade III or IV), retinopathy of prematurity requiring treatment, necrotizing enterocolitis (grade II or higher), bronchopulmonary dysplasia, neonatal sepsis, and/or cystic periventricular leukomalacia (grade II or higher)
研究者
PI-NL Research Team
Scientific
Amsterdam UMC
研究点 (8)
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