Pre-eclampsia Intervention 3 Trial: a double blind randomised, placebo-controlled trial of metformin to treat preterm pre-eclampsia

Stellenbosch University0 个研究点目标入组 500 人开始时间: 2021年3月29日最近更新: 2023年5月29日

试验速览

阶段: 3 期
状态: 招募中
发起方: Stellenbosch University
入组人数: 500

研究概览入排标准研究者记录与标识符相似试验

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: 19 Year(s) 至 44 Year(s)（—）
性别: Female

入选标准

•A diagnosis of pre-eclampsia, gestational hypertension with evidence of pre-eclampsia, preexisting hypertension with evidence of pre-eclampsia or unclassified proteinuric hypertension has been made by the attending clinician who believes the patient and fetus would benefit from expectant management.
•AND all of the following are present:
•Gestational age between 26 + 0 weeks and 31 + 6 weeks
•Estimated fetal weight by ultrasound between 500gm and 1800 gm (if gestation is not certain)
•Singleton pregnancy
•The managing clinicians have made the assessment to proceed with expectant management and that delivery is not expected within 48 hours
•The managing clinician and neonatologist believe that the fetus could potentially be delivered in a viable condition.
•The mother must be able to understand the information provided, with the use of an interpreter if needed, and must be able to give informed consent
•Patient will be admitted to hospital for expectant management and standard care
•Mother must be older than 18 years of age.

排除标准

•Patient is unable or unwilling to give consent
•Established fetal compromise that necessitates delivery. This will be decided by the clinical team before expectant management is offered to the patient.
•Suspicion of a major known fetal anomaly or malformation. A major fetal anomaly is defined as anomalies or malformations that create significant medical problems for the patient or that require specific surgical or medical management. Major anomalies or malformations are not considered a variation of the normal spectrum.
•The presence of any of the following at presentation (given these are typically contra-indications to expectant management):
•?Eclampsia defined as the new onset of grand mal seizure activity and/or an unexplained coma during pregnancy with signs or symptoms of pre-eclampsia.51,52
•?Severe hypertension defined as a systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 110 mmHg that cannot be controlled with antihypertensive medication within 48 hours of admission.
•?Cerebrovascular event defined as an ischaemic or haemorrhagic stroke associated with clinical symptoms and definitive signs on imaging.
•?Posterior reversible encephalopathy syndrome (PRES) associated with pre-eclampsia defined on imaging as reversible vasogenic oedema, usually in the occipital or parietal lobes.
•?Severe renal impairment with a creatinine level of greater or equal to 125 µmol/l or a need for dialysis.
•?Signs of left ventricular failure which include pulmonary oedema requiring treatment or oxygen saturations of less than 90% caused by left sided heart failure.
•?Disseminated intravascular coagulation defined as an INR greater than 2
•?Platelet count at presentation less than 50x109 (platelet aggregation excluded)
•?Haemolysis, elevated liver enzymes and low platelets (HELLP) syndrome defined as a platelet count less than 100 × 109/L, aspartate aminotransferase greater than 70 µ/L, and haemolysis as demonstrated by lactate dehydrogenase > 600 µ/L or haemolysis on a peripheral blood smear.
•?Liver transaminases (aspartate aminotransferase and/or alanine transferase) greater than or equal to 500IU/L
•?Liver haematoma or rupture
•?Fetal distress on cardiotocography
•?Severe ascites on ultrasound as defined by the sonographer
•Contra-indications for expectant management of pre-eclampsia
•Current use of metformin or a clinical indication for the use of metformin
•Contraindications to the use of metformin
•?Renal disease or dysfunction, suggested by a creatinine level greater than or equal to 125umol/L
•?Known hypersensitivity to metformin
•?Acute or chronic metabolic acidosis, including diabetic ketoacidosis
•Current use of a drug that may be affected by metformin
•?Furosemide
•?Cationic drugs (amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim and vancomycin)

研究者

发起方

Stellenbosch University

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