PACTR201504000771349已完成未知
The Preeclampsia Intervention with esomeprazole (PIE)trial: a double blind randomised, placebo-controlled trial to treat early onset severe preeclampsia
niversity of Stellenbosch0 个研究点目标入组 120 人开始时间: 2014年2月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
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
- 16 Year(s) 至 50 Year(s)（—）
- 性别
- Female
入选标准
- •Diagnosis of preeclampsia, super-imposed preeclampsia unclassified or proteinuric hypertension AND all of the following
- •Gestational age between 26 + 0 weeks and 31 + 6 weeks
- •Estimated fetal weight by ultrasound between 500gm and 2000gm, (if gestation is not certain)
- •Singleton pregnancy
- •The managing clinicians have made the initial assessment at initial diagnosis to proceed with expectant management and that delivery is not expected within 48 hours
- •The managing clinician and neonatologist believe that the fetus could be potentially delivered viable
- •No suspicions of a major fetal anomaly
- •The mother must be able to understand the information provided, with the use of an interpreter if needed
- •The mother must be able to give informed consent
- •Patient will be admitted to hospital for expectant management and standardized care
排除标准
- •Patient is unable or unwilling to give consent
- •Established fetal compromise that necessitates delivery
- •The presence of any of the following at presentation:
- •1.Eclampsia
- •2.Severe hypertension (systolic blood pressure greater than 170 or diastolic blood pressure greater than 110) that cannot be controlled with antihypertensive medication within 48 hours of admission
- •3.Cerebrovascular event
- •4.Severe renal impairment needing delivery
- •5.Haemolysis
- •6.Signs of left ventricular failure (pulmonary oedema requiring treatment; oxygen saturations of less than 95% caused by left sided heart failure)
- •7.Disseminated intravascular coagulation
- •8.Platelet count at presentation less than 50x109 (platelet aggregation excluded)
- •9.Haemolysis, elevated liver enzymes and low platelets (HELLP) syndrome defined as a platelet count less than 100 × 109/L, aspartate aminotransferase greater than 40 ¿/L, alanine aminotransferase greater than 53 ¿/L and haemolysis as demonstrated by lactate dehydrogenase > 350 ¿/L or haemolysis on a peripheral blood smear or a raised haptoglobin level)
- •10.Liver transaminases >300IU/L;
- •11.Liver haematoma
- •12.Fetal distress on cardiotocography
- •13.Severe ascites on ultrasound
- •Contraindications for expectant management of pre-eclampsia
- •Current use of a proton pump inhibitor
- •Contraindications to the use of a proton pump inhibitor
- •Previous hypersensitivity reaction to a proton pump inhibitor
- •Current use of a drug that may be affected by a proton pump inhibitor: warfarin, ketoconazole, voriconazole, atazanavir, nelfinavir, saquinavir, digoxin, St John¿s Wort, rifampin, cilostazol, diazepam, tacrolimus, erlotinib, methotrexate and clopidogrel.
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