Preeclampsia and role of metformin in reducing incidence and severity of complications (PROMISE Trial) â?? Placebo controlled Randomized Clinical Trial - PROMISE Trial

JIPMER0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月29日

试验速览

暂无简介。

•All parous women more than 18-45 years with
•a diagnosis of one of the following:
•a.Pre-eclampsia
•b.Preexisting hypertension with evidence of pre-eclampsia
•c.Unclassified proteinuric hypertension
•Satisfying all these criteria
•d.Gestational age between 20 weeks and 36 weeks
•e.Singleton pregnancy
•f.The managing clinicians have made the assessment to proceed with expectant management and that delivery is not expected within 48â??hours
•g.The managing clinician and neonatologist believe that the fetus could potentially be delivered in a viable condition
•h.No suspicions of a major fetal anomaly or malformations.
•i.The patient will be admitted to the hospital for expectant management and standardized care

•Established fetal compromise that necessitates delivery
•Cerebrovascular event
•Posterior reversible encephalopathy syndrome
•Severe renal impairment, defined as a creatinine level >=125 Î¼mol/l or a need for dialysis
•Pulmonary oedema
•Left-sided heart failure
•Disseminated intravascular coagulation
•Platelet count <50Ã?109
•Haemolysis, elevated liver enzymes and low platelets syn-drome
•Liver transaminases >500 IU/L
•Liver hematoma or rupture
•Ascites ( >500 ml)
•Contraindications or a hypersensitivity reaction to the use of metformin

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