CTIS2022-502707-29-00招募中1 期
Preeclampsia Intervention 4 – A double blind phase III randomised controlled trial assessing metformin to prolong gestation in preterm preeclampsia - PI4
Vastra Gotalandsregionen0 个研究点目标入组 294 人开始时间: 2023年3月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 294
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 64（—）
- 性别
- All
入选标准
- •A diagnosis of preeclampsia has been made by the attending clinician, •The managing clinicians have made the assessment to proceed with expectant management and that delivery is not expected within 48 hours, •The subject has given written consent to participate in the study., •The woman must be 18 years of age or older, •The gestational age is between 22+0 weeks to 33+6 weeks with a viable fetus, •The woman carries a singleton pregnancy
排除标准
- •There are contraindications to treatment with metformin as outlined in SmPC (Attachment E), •Not suitable for inclusion by the opinion of the investigator, •Contraindications for expectant management of preeclampsia such as an immediate indication for delivery according to Swedish guidelines., Current use of metformin, •Known or suspected allergies against metformin, •Reluctance or language difficulties that result in difficulty understanding the meaning of study participation, •Unable to understand the informed consent process, •Previous participation in the study, •Established fetal compromise that necessitates imminent delivery (including planned delivery after 48 hours of corticosteroid treatment). This will be decided by the clinical team before expectant management is offered to the patient., Diabetes type 1, •Suspicion of a major known fetal anomaly or malformation., •Renal disease or dysfunction, suggested by a creatinine level greater than or equal to 125 µmol/L or rapidly declining renal function, •Known acute or chronic metabolic acidosis, including diabetic ketoacidosis
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